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Review
. 2014 Jan 10;2014(1):CD007470.
doi: 10.1002/14651858.CD007470.pub3.

Vitamin D supplementation for prevention of mortality in adults

Goran Bjelakovic  1 , Lise Lotte Gluud, Dimitrinka Nikolova, Kate Whitfield, Jørn Wetterslev, Rosa G Simonetti, Marija Bjelakovic, Christian Gluud
Affiliations
Review

Vitamin D supplementation for prevention of mortality in adults

Goran Bjelakovic et al. Cochrane Database Syst Rev. .

Abstract

Background: Available evidence on the effects of vitamin D on mortality has been inconclusive. In a recent systematic review, we found evidence that vitamin D3 may decrease mortality in mostly elderly women. The present systematic review updates and reassesses the benefits and harms of vitamin D supplementation used in primary and secondary prophylaxis of mortality.

Objectives: To assess the beneficial and harmful effects of vitamin D supplementation for prevention of mortality in healthy adults and adults in a stable phase of disease.

Search methods: We searched The Cochrane Library, MEDLINE, EMBASE, LILACS, the Science Citation Index-Expanded and Conference Proceedings Citation Index-Science (all up to February 2012). We checked references of included trials and pharmaceutical companies for unidentified relevant trials.

Selection criteria: Randomised trials that compared any type of vitamin D in any dose with any duration and route of administration versus placebo or no intervention in adult participants. Participants could have been recruited from the general population or from patients diagnosed with a disease in a stable phase. Vitamin D could have been administered as supplemental vitamin D (vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol)) or as an active form of vitamin D (1α-hydroxyvitamin D (alfacalcidol) or 1,25-dihydroxyvitamin D (calcitriol)).

Data collection and analysis: Six review authors extracted data independently. Random-effects and fixed-effect meta-analyses were conducted. For dichotomous outcomes, we calculated the risk ratios (RRs). To account for trials with zero events, we performed meta-analyses of dichotomous data using risk differences (RDs) and empirical continuity corrections. We used published data and data obtained by contacting trial authors.To minimise the risk of systematic error, we assessed the risk of bias of the included trials. Trial sequential analyses controlled the risk of random errors possibly caused by cumulative meta-analyses.

Main results: We identified 159 randomised clinical trials. Ninety-four trials reported no mortality, and nine trials reported mortality but did not report in which intervention group the mortality occurred. Accordingly, 56 randomised trials with 95,286 participants provided usable data on mortality. The age of participants ranged from 18 to 107 years. Most trials included women older than 70 years. The mean proportion of women was 77%. Forty-eight of the trials randomly assigned 94,491 healthy participants. Of these, four trials included healthy volunteers, nine trials included postmenopausal women and 35 trials included older people living on their own or in institutional care. The remaining eight trials randomly assigned 795 participants with neurological, cardiovascular, respiratory or rheumatoid diseases. Vitamin D was administered for a weighted mean of 4.4 years. More than half of the trials had a low risk of bias. All trials were conducted in high-income countries. Forty-five trials (80%) reported the baseline vitamin D status of participants based on serum 25-hydroxyvitamin D levels. Participants in 19 trials had vitamin D adequacy (at or above 20 ng/mL). Participants in the remaining 26 trials had vitamin D insufficiency (less than 20 ng/mL).Vitamin D decreased mortality in all 56 trials analysed together (5,920/47,472 (12.5%) vs 6,077/47,814 (12.7%); RR 0.97 (95% confidence interval (CI) 0.94 to 0.99); P = 0.02; I(2) = 0%). More than 8% of participants dropped out. 'Worst-best case' and 'best-worst case' scenario analyses demonstrated that vitamin D could be associated with a dramatic increase or decrease in mortality. When different forms of vitamin D were assessed in separate analyses, only vitamin D3 decreased mortality (4,153/37,817 (11.0%) vs 4,340/38,110 (11.4%); RR 0.94 (95% CI 0.91 to 0.98); P = 0.002; I(2) = 0%; 75,927 participants; 38 trials). Vitamin D2, alfacalcidol and calcitriol did not significantly affect mortality. A subgroup analysis of trials at high risk of bias suggested that vitamin D2 may even increase mortality, but this finding could be due to random errors. Trial sequential analysis supported our finding regarding vitamin D3, with the cumulative Z-score breaking the trial sequential monitoring boundary for benefit, corresponding to 150 people treated over five years to prevent one additional death. We did not observe any statistically significant differences in the effect of vitamin D on mortality in subgroup analyses of trials at low risk of bias compared with trials at high risk of bias; of trials using placebo compared with trials using no intervention in the control group; of trials with no risk of industry bias compared with trials with risk of industry bias; of trials assessing primary prevention compared with trials assessing secondary prevention; of trials including participants with vitamin D level below 20 ng/mL at entry compared with trials including participants with vitamin D levels equal to or greater than 20 ng/mL at entry; of trials including ambulatory participants compared with trials including institutionalised participants; of trials using concomitant calcium supplementation compared with trials without calcium; of trials using a dose below 800 IU per day compared with trials using doses above 800 IU per day; and of trials including only women compared with trials including both sexes or only men. Vitamin D3 statistically significantly decreased cancer mortality (RR 0.88 (95% CI 0.78 to 0.98); P = 0.02; I(2) = 0%; 44,492 participants; 4 trials). Vitamin D3 combined with calcium increased the risk of nephrolithiasis (RR 1.17 (95% CI 1.02 to 1.34); P = 0.02; I(2) = 0%; 42,876 participants; 4 trials). Alfacalcidol and calcitriol increased the risk of hypercalcaemia (RR 3.18 (95% CI 1.17 to 8.68); P = 0.02; I(2) = 17%; 710 participants; 3 trials).

Authors' conclusions: Vitamin D3 seemed to decrease mortality in elderly people living independently or in institutional care. Vitamin D2, alfacalcidol and calcitriol had no statistically significant beneficial effects on mortality. Vitamin D3 combined with calcium increased nephrolithiasis. Both alfacalcidol and calcitriol increased hypercalcaemia. Because of risks of attrition bias originating from substantial dropout of participants and of outcome reporting bias due to a number of trials not reporting on mortality, as well as a number of other weaknesses in our evidence, further placebo-controlled randomised trials seem warranted.

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Conflict of interest statement

None known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias according to bias domains in the 56 randomised clinical trials on vitamin D and mortality.
3
3
Risk of bias in the included 56 randomised clinical trials on vitamin D and mortality.
4
4
Trial sequential analysis on mortality in 38 vitamin D3 trials 
 The diversity‐adjusted required information size (RIS) was calculated based on mortality in the control group of 10%; relative risk reduction of 5% in the experimental group; type I error of 5%; and type II error of 20% (80% power). No diversity was noted. The required information size was 110,505 participants. The cumulative Z‐curve (blue line) crossed the trial sequential monitoring boundaries for benefit (red inward sloping line) after the 22nd trial. Accordingly, the risk of random error in the finding seems acceptable according to the O'Brien Fleming stopping rule for an individual trial interim analysis. Subsequently, 16 trials have been published.
5
5
Trial sequential analysis on mortality in the 13 trials that administered low dose of vitamin D3 (i.e. a dose less than 800 IU per day) 
 The diversity‐adjusted required information size (RIS) was calculated based on mortality in the control group of 10%; relative risk reduction of 5% in the experimental group; type I error of 5%; and type II error of 20% (80% power). No diversity was noted. The required information size was 110,505 participants. The cumulative Z‐curve (blue line) did not cross the trial sequential monitoring boundaries for benefit (red line) at any time. Accordingly, the crossing of the conventional statistical 5% boundary (the horizontal brown line) may be due to random errors.
6
6
Trial sequential analysis of mortality in 12 vitamin D2 trials 
 The diversity‐adjusted required information size (RIS) was conducted based on 10% mortality in the control group; relative risk reduction of 10% in the experimental group; type I error of 5%; and type II error of 20% (80% power). No diversity was noted. The required information size was 27,585 participants. The cumulative Z‐curve (blue line) crossed the trial sequential monitoring boundaries for futility (red outward sloping line) after the eighth trial.
1.1
1.1. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 1 All‐cause mortality in trials with low or high risk of bias.
1.2
1.2. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 2 All‐cause mortality in individually randomised and cluster‐randomised trials.
1.3
1.3. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 3 All‐cause mortality in placebo‐controlled and no intervention trials.
1.4
1.4. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 4 All‐cause mortality and risk of industry bias.
1.5
1.5. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 5 All‐cause mortality in primary and secondary prevention trials.
1.6
1.6. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 6 All‐cause mortality and vitamin D status.
1.7
1.7. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 7 All‐cause mortality in ambulatory and institutionalised participants.
1.8
1.8. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 8 All‐cause mortality ('best‐worst case' and 'worst‐best case' scenario).
1.9
1.9. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 9 All‐cause mortality in trials using vitamin D3 (cholecalciferol).
1.10
1.10. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 10 All‐cause mortality in trials using vitamin D3 singly or combined with calcium.
1.11
1.11. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 11 All‐cause mortality in trials using low or high dose of vitamin D3.
1.12
1.12. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 12 All‐cause mortality in trials applying vitamin D3 daily or intermittently.
1.13
1.13. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 13 All‐cause mortality in trials using vitamin D3 and vitamin D status.
1.14
1.14. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 14 All‐cause mortality in trials using vitamin D3 according to the participant's sex.
1.15
1.15. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 15 All‐cause mortality in trials using vitamin D2 (ergocalciferol).
1.16
1.16. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 16 All‐cause mortality in trials using vitamin D2 singly or combined with calcium.
1.17
1.17. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 17 All‐cause mortality in trials using low or high dose of vitamin D2.
1.18
1.18. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 18 All‐cause mortality in trials applying vitamin D2 daily or intermittently.
1.19
1.19. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 19 All‐cause mortality in trials using vitamin D2 and vitamin D status.
1.20
1.20. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 20 All‐cause mortality in trials using alfacalcidol (1α‐hydroxyvitamin D).
1.21
1.21. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 21 All‐cause mortality in trials using alfacalcidol and vitamin D status.
1.22
1.22. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 22 All‐cause mortality in trials using calcitriol (1,25‐dihydroxyvitamin D).
1.23
1.23. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 23 All‐cause mortality in trials using calcitriol and vitamin D status.
1.24
1.24. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 24 Cancer mortality.
1.25
1.25. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 25 Cardiovascular mortality.
1.26
1.26. Analysis
Comparison 1 Vitamin D versus placebo or no intervention, Outcome 26 Adverse events.
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    1. Heikkinen AM, Tuppurainen MT, Niskanen L, Komulainen M, Penttilä I, Saarikoski S, et al. Long‐term vitamin D3 supplementation may have adverse effects on serum lipids during postmenopausal hormone replacement therapy. European Journal of Endocrinology/European Federation of Endocrine Societies 1997;137(5):495‐502. - PubMed
    1. Komulainen M, Kröger H, Tuppurainen MT, Heikkinen AM, Alhava E, Honkanen R, et al. Prevention of femoral and lumbar bone loss with hormone replacement therapy and vitamin D3 in early postmenopausal women: a population‐based 5‐year randomized trial. Journal of Clinical Endocrinology and Metabolism 1999;84(2):546‐52. - PubMed
    1. Komulainen M, Kröger H, Tuppurainen MT, Heikkinen AM, Honkanen R, Saarikoski S. Identification of early postmenopausal women with no bone response to HRT: results of a five‐year clinical trial. Osteoporosis International 2000;11(3):211‐8. - PubMed
Krieg 1999 {published data only}
    1. Krieg MA, Jacquet AF, Bremgartner M, Cuttelod S, Thiébaud D, Burckhardt P. Effect of supplementation with vitamin D3 and calcium on quantitative ultrasound of bone in elderly institutionalized women: a longitudinal study. Osteoporosis International 1999;9(6):483‐8. - PubMed
Lappe 2007 {published data only}
    1. Bolland MJ, Reid IR. Calcium supplementation and cancer incidence. American Journal of Clinical Nutrition 2008;87(3):792‐3. - PubMed
    1. Lappe JM, Davies KM, Travers‐Gustafson D, Heaney RP. Vitamin D status in a rural postmenopausal female population. Journal of the American College of Nutrition 2006;25(5):395‐402. - PubMed
    1. Lappe JM, Travers‐Gustafson D, Davies KM, Recker RR, Heaney RP. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. American Journal of Clinical Nutrition 2007;85(6):1586‐91. - PubMed
    1. Ojha RP, Felini MJ, Fischbach LA. Vitamin D for cancer prevention: valid assertion or premature anointment. American Journal of Clinical Nutrition 2007;86(6):1804‐5. - PubMed
    1. Schabas R. Artifact in the control group undermines the conclusions of a vitamin D and cancer study. American Journal of Clinical Nutrition 2008;87(3):792. - PubMed
Larsen 2004 {published data only}
    1. Larsen ER, Mosekilde L, Foldspang A. Determinants of acceptance of a community‐based program for the prevention of falls and fractures among the elderly. Preventive Medicine 2001;33(2 Pt 1):115‐9. - PubMed
    1. Larsen ER, Mosekilde L, Foldspang A. Vitamin D and calcium supplementation prevents osteoporotic fractures in elderly community dwelling residents: a pragmatic population‐based 3‐year intervention study. Journal of Bone and Mineral Research 2004;19(3):370‐8. - PubMed
    1. Larsen ER, Mosekilde L, Foldspang A. Vitamin D and calcium supplementation prevents severe falls in elderly community‐dwelling women: a pragmatic population‐based 3‐year intervention study. Aging Clinical and Experimental Research 2005;17(2):125‐32. - PubMed
Latham 2003 {published data only}
    1. Latham NK, Anderson CS, Lee A, Bennett DA, Moseley A, Cameron ID, et al. A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS). Journal of the American Geriatrics Society 2003;51(3):291‐9. - PubMed
Law 2006 {published data only}
    1. Grant WB. Cholecalciferol, not ergocalciferol, should be used for vitamin D supplementation. Age and Ageing 2006;35(6):645. - PubMed
    1. Law M, Withers H, Morris J, Anderson F. Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in residential accommodation. Age and Ageing 2006;35(5):482‐6. - PubMed
    1. Zeimer H. Vitamin D supplementation and the prevention of fractures and falls. Age and Ageing 2006;36(2):232‐3. - PubMed
Lehouck 2012 {published data only}
    1. Lehouck A, Mathieu C, Carremans C, Baeke F, Verhaegen J, Eldere J, et al. High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial. Annals of Internal Medicine 2012;156(2):105‐14. - PubMed
Lips 1996 {published data only}
    1. Graafmans WC, Lips P, Ooms ME, Leeuwen JP, Pols HA, Uitterlinden AG. The effect of vitamin D supplementation on the bone mineral density of the femoral neck is associated with vitamin D receptor genotype. Journal of Bone and Mineral Research 1997;12(8):1241‐5. - PubMed
    1. Lips P, Graafmans WC, Ooms ME, Bezemer PD, Bouter LM. Vitamin D supplementation and fracture incidence in elderly persons. A randomized, placebo‐controlled clinical trial. Annals of Internal Medicine 1996;124(4):400‐6. - PubMed
Lips 2010 {published data only}
    1. Lips P, Binkley N, Pfeifer M, Recker R, Samanta S, Cohn DA, et al. Once‐weekly dose of 8400 IU vitamin D(3) compared with placebo: effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency. American Journal of Clinical Nutrition 2010;91(4):985‐91. - PubMed
Lyons 2007 {published data only}
    1. Lyons RA, Johansen A, Brophy S, Newcombe RG, Phillips CJ, Lervy B, et al. Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation. Osteoporosis International 2007;18(6):811‐8. - PubMed
Meier 2004 {published data only}
    1. Meier C, Woitge HW, Witte K, Lemmer B, Seibel MJ. Supplementation with oral vitamin D3 and calcium during winter prevents seasonal bone loss: a randomized controlled open‐label prospective trial. Journal of Bone and Mineral Research 2004;19(8):1221‐30. - PubMed
Moschonis 2006 {published data only}
    1. Manios Y, Moschonis G, Koutsikas K, Papoutsou S, Petraki I, Bellou E, et al. Changes in body composition following a dietary and lifestyle intervention trial: the postmenopausal health study. Maturitas 2009;62(1):58‐65. - PubMed
    1. Manios Y, Moschonis G, Lyritis GP. Seasonal variations of vitamin D status in Greek postmenopausal women receiving enriched dairy products for 30 months: the Postmenopausal Health Study. European Journal of Clinical Nutrition 2011;65(3):412‐4. - PubMed
    1. Manios Y, Moschonis G, Panagiotakos DB, Farajian P, Trovas G, Lyritis GP. Changes in biochemical indices of bone metabolism in post‐menopausal women following a dietary intervention with fortified dairy products. Journal of Human Nutrition and Dietetics 2009;22(2):156‐65. - PubMed
    1. Manios Y, Moschonis G, Trovas G, Lyritis GP. Changes in biochemical indexes of bone metabolism and bone mineral density after a 12‐mo dietary intervention program: the Postmenopausal Health Study. American Journal of Clinical Nutrition 2007;86(3):781‐9. - PubMed
    1. Moschonis G, Katsaroli I, Lyritis GP, Manios Y. The effects of a 30‐month dietary intervention on bone mineral density: the Postmenopausal Health Study. British Journal of Nutrition 2010;104(1):100‐7. - PubMed
Ooms 1995 {published data only}
    1. Graafmans WC, Ooms ME, Hofstee HM, Bezemer PD, Bouter LM, Lips P. Falls in the elderly: a prospective study of risk factors and risk profiles. American Journal of Epidemiology 1996;143(11):1129‐36. - PubMed
    1. Lips P, Ooms ME, Ter Schegget RM. Prevention of hip fractures in the elderly by vitamin D supplementation. In: Christiansen C, Overgaard K editor(s). Osteoporosis. Copenhagen, Denmark: Osteopress Aps, 1990:604‐6.
    1. Ooms ME, Roos JC, Bezemer PD, Vijgh WJ, Bouter LM, Lips P. Prevention of bone loss by vitamin D supplementation in elderly women: a randomized double‐blind trial. Journal of Clinical Endocrinology and Metabolism 1995;80(4):1052‐8. - PubMed
Ott 1989 {published data only}
    1. Ott SM, Chesnut CH 3rd. Calcitriol treatment is not effective in postmenopausal osteoporosis. Annals of Internal Medicine 1989;110(4):267‐74. - PubMed
Porthouse 2005 {published data only}
    1. Allain TJ. Vitamin D and fracture prevention‐‐treatment still indicated but clarification needed. Age and Ageing 2005;34(6):542‐4. - PubMed
    1. Dumville JC, Miles JN, Porthouse J, Cockayne S, Saxon L, King C. Can vitamin D supplementation prevent winter‐time blues? A randomised trial among older women. Journal of Nutrition, Health and Aging 2006;10(2):151‐3. - PubMed
    1. Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, et al. Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. BMJ 2005;330(7498):1003. - PMC - PubMed
    1. Radecki TE. Calcium and vitamin D in preventing fractures: vitamin K supplementation has powerful effect. BMJ 2005;331(7508):108. - PMC - PubMed
    1. Vasquez A, Cannell J. Calcium and vitamin D in preventing fractures: data are not sufficient to show inefficacy. BMJ 2005;331(7508):108‐9. - PMC - PubMed
Prince 2008 {published data only}
    1. Prince RL, Austin N, Devine A, Dick IM, Bruce D, Zhu K. Effects of ergocalciferol added to calcium on the risk of falls in elderly high‐risk women. Archives of Internal Medicine 2008;168(1):103‐8. - PubMed
    1. Zhu K, Bruce D, Austin N, Devine A, Ebeling PR, Prince RL. Randomized controlled trial of the effects of calcium with or without vitamin D on bone structure and bone‐related chemistry in elderly women with vitamin D insufficiency. Journal of Bone and Mineral Research 2008;23(8):1343‐8. - PubMed
Sanders 2010 {published data only}
    1. Sanders KM, Stuart AL, Merriman EN, Read ML, Kotowicz MA, Young D, et al. Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study. BMC Medical Research Methodology 2009;9:78. - PMC - PubMed
    1. Sanders KM, Stuart AL, Williamson EJ, Jacka FN, Dodd S, Nicholson G, et al. Annual high‐dose vitamin D3 and mental well‐being: randomised controlled trial. British Journal of Psychiatry 2011;198(5):357‐64. - PubMed
    1. Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, et al. Annual high‐dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. JAMA 2010;303(18):1815‐22. - PubMed
Sato 1997 {published data only}
    1. Sato Y, Maruoka H, Oizumi K. Amelioration of hemiplegia‐associated osteopenia more than 4 years after stroke by 1 alpha‐hydroxyvitamin D3 and calcium supplementation. Stroke 1997;28(4):736‐9. - PubMed
Sato 1999a {published data only}
    1. Sato Y, Manabe S, Kuno H, Oizumi K. Amelioration of osteopenia and hypovitaminosis D by 1alpha‐hydroxyvitamin D3 in elderly patients with Parkinson's disease. Journal of Neurology, Neurosurgery and Psychiatry 1999;66(1):64‐8. - PMC - PubMed
Sato 1999b {published data only}
    1. Sato Y, Kuno H, Kaji M, Saruwatari N, Oizumi K. Effect of ipriflavone on bone in elderly hemiplegic stroke patients with hypovitaminosis D. American Journal of Physical Medicine and Rehabilitation 1999;78(5):457‐63. - PubMed
Sato 2005a {published data only}
    1. Sato Y, Iwamoto J, Kanoko T, Satoh K. Low‐dose vitamin D prevents muscular atrophy and reduces falls and hip fractures in women after stroke: a randomized controlled trial. Cerebrovascular Diseases 2005;20(3):187‐92. - PubMed
Schleithoff 2006 {published data only}
    1. Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, Koerfer R. Combined calcium and vitamin D supplementation is not superior to calcium supplementation alone in improving disturbed bone metabolism in patients with congestive heart failure. European Journal of Clinical Nutrition 2008;62(12):1388‐94. - PubMed
    1. Schleithoff SS, Zittermann A, Tenderich G, Berthold HK, Stehle P, Koerfer R. Vitamin D supplementation improves cytokine profiles in patients with congestive heart failure: a double‐blind, randomized, placebo‐controlled trial. American Journal of Clinical Nutrition 2006;83(4):754‐9. - PubMed
    1. Vieth R, Kimball S. Vitamin D in congestive heart failure. American Journal of Clinical Nutrition 2006;83(4):731‐2. - PubMed
Smith 2007 {published data only}
    1. Francis RM. The vitamin D paradox. Rheumatology (Oxford) 2007;46(12):1749‐50. - PubMed
    1. Smith H, Anderson F, Raphael H, Maslin P, Crozier S, Cooper C. Effect of annual intramuscular vitamin D on fracture risk in elderly men and women—a population‐based, randomized, double‐blind, placebo‐controlled trial. Rheumatology (Oxford) 2007;46(12):1852‐7. - PubMed
Trivedi 2003 {published data only}
    1. Trivedi DP, Doll R, Khaw KT. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. BMJ 2003;326(7387):469. - PMC - PubMed
Witham 2010 {published data only}
    1. Witham MD, Crighton LJ, Gillespie ND, Struthers AD, McMurdo ME. The effects of vitamin D supplementation on physical function and quality of life in older heart failure patients: a randomised controlled trial. Circulation Heart Failure 2010;3(2):195‐201. - PubMed
Zhu 2008 {published data only}
    1. Prince RL, Devine A, Dhaliwal SS, Dick IM. Effects of calcium supplementation on clinical fracture and bone structure: results of a 5‐year, double‐blind, placebo‐controlled trial in elderly women. Archives of Internal Medicine 2006;166(8):869‐75. - PubMed
    1. Zhu K, Devine A, Dick IM, Wilson SG, Prince RL. Effects of calcium and vitamin D supplementation on hip bone mineral density and calcium‐related analytes in elderly ambulatory Australian women: a five‐year randomized controlled trial. The Journal of Clinical Endocrinology and Metabolism 2008;93(3):743‐9. - PubMed

References to studies excluded from this review

Adachi 1996 {published data only}
    1. Adachi JD, Bensen WG, Bianchi F, Cividino A, Pillersdorf S, Sebaldt RJ, et al. Vitamin D and calcium in the prevention of corticosteroid induced osteoporosis: a 3 year follow‐up. Journal of Rheumatology 1996;23(6):995‐1000. - PubMed
Andersen 2008 {published data only}
    1. Andersen R, Mølgaard C, Skovgaard LT, Brot C, Cashman KD, Jakobsen J, et al. Effect of vitamin D supplementation on bone and vitamin D status among Pakistani immigrants in Denmark: a randomised double‐blinded placebo‐controlled intervention study. British Journal of Nutrition 2008;100(1):197‐207. - PubMed
Arthur 1990 {published data only}
    1. Arthur RS, Piraino B, Candib D, Cooperstein L, Chen T, West C, et al. Effect of low‐dose calcitriol and calcium therapy on bone histomorphometry and urinary calcium excretion in osteopenic women. Mineral and Electrolyte Metabolism 1990;16(6):385‐90. - PubMed
Bacon 2008 {published data only}
    1. Bacon CJ, Gamble GD, Horne AM, Scott MA, Reid IR. High‐dose oral vitamin D(3) supplementation in the elderly. Osteoporosis International 2008;20(8):1407‐15. - PubMed
Bernstein 1996 {published data only}
    1. Bernstein CN, Seeger LL, Anton PA, Artinian L, Geffrey S, Goodman W, et al. A randomized, placebo‐controlled trial of calcium supplementation for decreased bone density in corticosteroid‐using patients with inflammatory bowel disease: a pilot study. Alimentary Pharmacology and Therapeutics 1996;10(5):777‐86. - PubMed
Berry 2010 {published data only}
    1. Berry SD, Misra D, Hannan MT, Kiel DP. Low acceptance of treatment in the elderly for the secondary prevention of osteoporotic fracture in the acute rehabilitation setting. Aging Clinical and Experimental Research 2010;22(3):231‐7. - PMC - PubMed
Binkley 2011 {published data only}
    1. Binkley N, Gemar D, Engelke J, Gangnon R, Ramamurthy R, Krueger D, et al. Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. Journal of Clinical Endocrinology and Metabolism 2011;96(4):981‐8. - PMC - PubMed
Bischoff‐Ferrari 2010a {published data only}
    1. Bischoff‐Ferrari HA, Dawson‐Hughes B, Platz A, Orav EJ, Stähelin HB, Willett WC, et al. Effect of high‐dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial. Archives of Internal Medicine 2010;170(9):813‐20. - PubMed
Bizzarri 2010 {published data only}
    1. Bizzarri C, Pitocco D, Napoli N, Stasio E, Maggi D, Manfrini S, et al. No protective effect of calcitriol on beta‐cell function in recent‐onset type 1 diabetes: the IMDIAB XIII trial. Diabetes Care 2010;33(9):1962‐3. - PMC - PubMed
Buckley 1996 {published data only}
    1. Buckley LM, Leib ES, Cartularo KS, Vacek PM, Cooper SM. Calcium and vitamin D3 supplementation prevents bone loss in the spine secondary to low‐dose corticosteroids in patients with rheumatoid arthritis. A randomized, double‐blind, placebo‐controlled trial. Annals of Internal Medicine 1996;125(12):961‐8. - PubMed
Caniggia 1992 {published data only}
    1. Caniggia A, Loré F, Nuti R, Martini G, Frediani B, Cairano G. Role of the active vitamin D metabolite and 1 alpha‐hydroxylated analogs in the treatment of postmenopausal osteoporosis. Journal of Nutritional Science and Vitaminology 1992;Spec No:232‐5. - PubMed
Chapuy 1996 {published data only}
    1. Chapuy MC, Chapuy P, Thomas JL, Hazard MC, Meunier PJ. Biochemical effects of calcium and vitamin D supplementation in elderly, institutionalized, vitamin D‐deficient patients. Revue du Rhumatisme (English ed.) 1996;63(2):135‐40. - PubMed
Chen 2001 {published data only}
    1. Chen M, Chow SN. Additive effect of alfacalcidol on bone mineral density of the lumbar spine in Taiwanese postmenopausal women treated with hormone replacement therapy and calcium supplementation: a randomized 2‐year study. Clinical Endocrinology 2001;55(2):253‐8. - PubMed
Dawson‐Hughes 1995 {published data only}
    1. Dawson‐Hughes B, Harris SS, Krall EA, Dallal GE, Falconer G, Green CL. Rates of bone loss in postmenopausal women randomly assigned to one of two dosages of vitamin D. American Journal of Clinical Nutrition 1995;61(5):1140‐5. - PubMed
den Uyl 2010 {published data only}
    1. Uyl D, Geusens PP, Berkum FN, Houben HH, Jebbink MC, Lems WF. Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross‐over trial. Clinical Rheumatology 2010;29(5):465‐72. - PMC - PubMed
Diamond 2005 {published data only}
    1. Diamond TH, Ho KW, Rohl PG, Meerkin M. Annual intramuscular injection of a megadose of cholecalciferol for treatment of vitamin D deficiency: efficacy and safety data. The Medical Journal of Australia 2005;183(1):10‐2. - PubMed
Dykman 1984 {published data only}
    1. Dykman TR, Haralson KM, Gluck OS, Murphy WA, Teitelbaum SL, Hahn TJ, et al. Effect of oral 1,25‐dihydroxyvitamin D and calcium on glucocorticoid‐induced osteopenia in patients with rheumatic diseases. Arthritis and Rheumatism 1984;27(12):1336‐43. - PubMed
Falch 1987 {published data only}
    1. Falch JA, Odegaard OR, Finnanger AM, Matheson I. Postmenopausal osteoporosis: no effect of three years treatment with 1,25‐dihydroxycholecalciferol. Acta Medica Scandinavica 1987;221(2):199‐204. - PubMed
Francis 1996 {published data only}
    1. Francis RM, Boyle IT, Moniz C, Sutcliffe AM, Davis BS, Beastall GH, et al. A comparison of the effects of alfacalcidol treatment and vitamin D2 supplementation on calcium absorption in elderly women with vertebral fractures. Osteoporosis International 1996;6(4):284‐90. - PubMed
Gallagher 1990 {published data only}
    1. Gallagher JC. Metabolic effects of synthetic calcitriol (Rocaltrol) in the treatment of postmenopausal osteoporosis. Metabolism 1990;39 Suppl 1(4):27‐9. - PubMed
    1. Gallagher JC, Goldgar D. Treatment of postmenopausal osteoporosis with high doses of synthetic calcitriol. A randomized controlled study. Annals of Internal Medicine 1990;113(9):649‐55. - PubMed
Gannage‐Yared 2003 {published data only}
    1. Gannagé‐Yared MH, Azoury M, Mansour I, Baddoura R, Halaby G, Naaman R. Effects of a short‐term calcium and vitamin D treatment on serum cytokines, bone markers, insulin and lipid concentrations in healthy post‐menopausal women. Journal of Endocrinological Investigation 2003;26(9):748‐53. - PubMed
Geusens 1986 {published data only}
    1. Geusens P, Dequeker J. Long‐term effect of nandrolone decanoate, 1 alpha‐hydroxyvitamin D3 or intermittent calcium infusion therapy on bone mineral content, bone remodeling and fracture rate in symptomatic osteoporosis: a double‐blind controlled study. Bone and MIneral 1986;1(4):347‐57. - PubMed
Giusti 2010 {published data only}
    1. Giusti A, Barone A, Pioli G, Girasole G, Razzano M, Pizzonia M, et al. Heterogeneity in serum 25‐hydroxy‐vitamin D response to cholecalciferol in elderly women with secondary hyperparathyroidism and vitamin D deficiency. Journal of the American Geriatrics Society 2010;58(8):1489‐95. - PubMed
Glendenning 2009 {published data only}
    1. Glendenning P, Chew GT, Seymour HM, Gillett MJ, Goldswain PR, Inderjeeth CA, et al. Serum 25‐hydroxyvitamin D levels in vitamin D‐insufficient hip fracture patients after supplementation with ergocalciferol and cholecalciferol. Bone 2009;45(5):870‐5. - PubMed
Goswami 2008a {published data only}
    1. Goswami R, Gupta N, Ray D, Singh N, Tomar N. Pattern of 25‐hydroxy vitamin D response at short (2 month) and long (1 year) interval after 8 weeks of oral supplementation with cholecalciferol in Asian Indians with chronic hypovitaminosis D. British Journal of Nutrition 2008;100(3):526‐9. - PubMed
Goussous 2005 {published data only}
    1. Goussous R, Song L, Dallal GE, Dawson‐Hughes B. Lack of effect of calcium intake on the 25‐hydroxyvitamin D response to oral vitamin D3. Journal of Clinical Endocrinology and Metabolism 2005;90(2):707‐11. - PubMed
Gupta 2010 {published data only}
    1. Gupta A, Gupta N, Singh N, Goswami R. Presence of impaired intestinal calcium absorption in chronic hypovitaminosis D and its change after cholecalciferol supplementation: assessment by the calcium load test. Journal of Human Nutrition and Dietetics 2010;23(1):54‐60. - PubMed
Heaney 2011 {published data only}
    1. Heaney RP, Recker RR, Grote J, Horst RL, Armas LA. Vitamin D(3) is more potent than vitamin D(2) in humans. Journal of Clinical Endocrinology and Metabolism 2011;96(3):E447‐52. - PubMed
Hedström 2002 {published data only}
    1. Hedström M, Sjöberg K, Brosjö E, Aström K, Sjöberg H, Dalén N. Positive effects of anabolic steroids, vitamin D and calcium on muscle mass, bone mineral density and clinical function after a hip fracture. A randomised study of 63 women. Journal of Bone and Joint Surgery. British Volume 2002;84(4):497‐503. - PubMed
Heikinheimo 1992 {published data only}
    1. Heikinheimo RJ, Inkovaara JA, Harju EJ, Haavisto MV, Kaarela RH, Kataja JM, et al. Annual injection of vitamin D and fractures of aged bones. Calcified Tissue International 1992;51(2):105‐10. - PubMed
Hill 2010 {published data only}
    1. Hill DA, Cacciatore M, Lamvu GM. Electronic prescribing influence on calcium supplementation: a randomized controlled trial. American Journal of Obstetrics and Gynecology 2010;202(3):236. - PubMed
Holecki 2008 {published data only}
    1. Holecki M, Zahorska‐Markiewicz B, Wiecek A, Mizia‐Stec K, Nieszporek T, Zak‐Golab A. Influence of calcium and vitamin D supplementation on weight and fat loss in obese women. Obesity Facts 2008;1(5):274‐9. - PMC - PubMed
Holick 2008b {published data only}
    1. Holick MF, Biancuzzo RM, Chen TC, Klein EK, Young A, Bibuld D, et al. Vitamin D2 is as effective as vitamin D3 in maintaining circulating concentrations of 25‐hydroxyvitamin D. Journal of Clinical Endocrinology and Metabolism 2008;93(3):677‐81. - PMC - PubMed
Holvik 2007 {published data only}
    1. Holvik K, Madar AA, Meyer HE, Lofthus CM, Stene LC. A randomised comparison of increase in serum 25‐hydroxyvitamin D concentration after 4 weeks of daily oral intake of 10 microg cholecalciferol from multivitamin tablets or fish oil capsules in healthy young adults. British Journal of Nutrition 2007;98(3):620‐5. - PubMed
Inkovaara 1983 {published data only}
    1. Inkovaara J, Gothoni G, Halttula R, Heikinheimo R, Tokola O. Calcium, vitamin D and anabolic steroid in treatment of aged bones: double‐blind placebo‐controlled long‐term clinical trial. Age and Ageing 1983;12(2):124‐30. - PubMed
Inomata 1986 {published data only}
    1. Inomata S, Kadowaki S, Yamatani T, Fukase M, Fujita T. Effect of 1 alpha (OH)‐vitamin D3 on insulin secretion in diabetes mellitus. Bone and Mineral 1986;1(3):187‐92. - PubMed
Ish‐Shalom 2008 {published data only}
    1. Ish‐Shalom S, Segal E, Salganik T, Raz B, Bromberg IL, Vieth R. Comparison of daily, weekly, and monthly vitamin D3 in ethanol dosing protocols for two months in elderly hip fracture patients. Journal of Endocrinology and Metabolism 2008;93(9):3430‐5. - PubMed
Iwamoto 2000 {published data only}
    1. Iwamoto J, Takeda T, Ichimura S. Effect of combined administration of vitamin D3 and vitamin K2 on bone mineral density of the lumbar spine in postmenopausal women with osteoporosis. Journal of Orthopaedic Science 2000;5(6):546‐51. - PubMed
Javanbakht 2011 {published data only}
    1. Javanbakht MH, Keshavarz SA, Djalali M, Siassi F, Eshraghian MR, Firooz A, et al. Randomized controlled trial using vitamins E and D supplementation in atopic dermatitis. Journal of Dermatological Treatment 2011;22(3):144‐50. - PubMed
Kamel 1996 {published data only}
    1. Kamel S, Brazier M, Rogez JC, Vincent O, Maamer M, Desmet G, et al. Different responses of free and peptide‐bound cross‐links to vitamin D and calcium supplementation in elderly women with vitamin D insufficiency. Journal of Endocrinology and Metabolism 1996;81(10):3717‐21. - PubMed
Keane 1992 {published data only}
    1. Keane EM, Rochfort A, Cox J, McGovern D, Coakley D, Walsh JB. Vitamin‐D‐fortified liquid milk—a highly effective method of vitamin D administration for house‐bound and institutionalised elderly. Gerontology 1992;38(5):280‐4. - PubMed
Kenny 2004 {published data only}
    1. Kenny AM, Prestwood KM, Biskup B, Robbins B, Zayas E, Kleppinger A, et al. Comparison of the effects of calcium loading with calcium citrate or calcium carbonate on bone turnover in postmenopausal women. Osteoporosis International 2004;15(4):290‐4. - PubMed
Kilpinen‐Loisa 2009 {published data only}
    1. Kilpinen‐Loisa P, Arvio M, Ilvesmäki V, Mäkitie O. Vitamin D status and optimal supplementation in institutionalized adults with intellectual disability. Journal of Intellectual Disability Research 2009;53(12):1014‐23. - PubMed
Lakatos 2000 {published data only}
    1. Lakatos P, Nagy Z, Kiss L, Horvath C, Takacs I, Foldes J, et al. Prevention of corticosteroid‐induced osteoporosis by alfacalcidol [Praevention der kortikosteroidinduzierten osteoporose durch alfacalcidol]. Zeitschrift für Rheumatologie 2000;59 Suppl 1:48‐52. - PubMed
Leventis 2009 {published data only}
    1. Leventis P, Kiely PD. The tolerability and biochemical effects of high‐dose bolus vitamin D2 and D3 supplementation in patients with vitamin D insufficiency. Scandinavian Journal of Rheumatology 2009;38(2):149‐53. - PubMed
Lind 1988 {published data only}
    1. Lind L, Wengle B, Lithell H, Ljunghall S. Plasma ionized calcium and cardiovascular risk factors in mild primary hyperparathyroidism: effects of long‐term treatment with active vitamin D (alphacalcidol). Journal of Internal Medicine 1992;231(4):427‐32. - PubMed
    1. Lind L, Wengle B, Lithell H, Ljunghall S. Reduction in serum alkaline phosphatase levels by treatment with active vitamin D (alphacalcidol) in primary and secondary hyperparathyroidism and in euparathyroid individuals. Scandinavian Journal of Urology and Nephrology 1991;25(3):233‐6. - PubMed
    1. Lind L, Wengle B, Ljunghall S. Blood pressure is lowered by vitamin D (alphacalcidol) during long‐term treatment of patients with intermittent hypercalcaemia. A double‐blind, placebo‐controlled study. Acta Medica Scandinavica 1987;222(5):423‐7. - PubMed
    1. Lind L, Wengle B, Sorensen OH, Wide L, Akerström G, Ljunghall S. Treatment with active vitamin D (alphacalcidol) in patients with mild primary hyperparathyroidism. Acta Endocrinologica 1989;120(2):250‐6. - PubMed
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Lind 1989c {published data only}
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Matsumoto 2010 {published data only}
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Nuti 2006 {published data only}
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Prestwood 1996 {published data only}
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Reginster 1999 {published data only}
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Reginster 2001 {published data only}
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Shipowick 2009 {published data only}
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    1. Slatkovska L, Alibhai SM, Beyene J, Hu H, Demaras A, Cheung AM. Effect of 12 months of whole‐body vibration therapy on bone density and structure in postmenopausal women: a randomized trial. Annals of Internal Medicine 2011;155(10):668‐79. - PubMed
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References to ongoing studies

Aloia 2008b {published data only}
    1. The interaction between calcium and vitamin D Intake. Ongoing study November 2008. Expected completion: 2009.
Baron 2004 {published data only}
    1. Vitamin D/calcium polyp prevention study. Ongoing study July 2004. Expected completion: December 2017.
Gallagher 2007 {published data only}
    1. Vitamin D supplementation in younger women. Ongoing study October 2007; Expected completion: January 2012.
Giovannucci 2007 {published data only}
    1. Vitamin D for chemoprevention. Ongoing study October 2007; Expected completion: October 2009.
Harris 2008 {published data only}
    1. Vitamin D, glucose control and insulin sensitivity in African‐Americans. Ongoing study July 2008; Expected completion: February 2011.
Manson 2009 {published data only}
    1. Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, et al. The VITamin D and OmegA‐3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega‐3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemporary Clinical Trials 2012;33(1):159‐71. - PMC - PubMed
Pande 2006 {published data only}
    1. A trial to study the effect of vitamin D supplementation on glucose and insulin metabolism in centrally obese men. Ongoing study July 2006; Expected completion: September 2006.
Schwartz 2008 {published data only}
    1. Effects of vitamin D on lipids. Ongoing study July 2008; Expected completion: April 2010.
Scragg 2011 {published data only}
    1. ViDA (vitamin D assessment) trial. Ongoing study 7/04/2011.
Shapses 2007 {published data only}
    1. The effect of vitamin D supplementation during caloric restriction on intestinal calcium absorption. Ongoing study March 2007; Expected completion: May 2011.
Witte 2009 {published data only}
    1. The impact of vitamin D supplementation in chronic heart failure. Ongoing study 01.01.2009; Expected completion: 31.12.2012.

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