Top

Published in:

01-06-2007 | Original Article

Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation

Authors: R. A. Lyons, A. Johansen, S. Brophy, R. G. Newcombe, C. J. Phillips, B. Lervy, R. Evans, K. Wareham, M. D. Stone

Published in: Osteoporosis International | Issue 6/2007

Abstract

Introduction

Osteoporotic fractures in older people are a major and increasing public health problem. We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation.

Methods

In a pragmatic double blind randomised controlled trial of 3 years duration, we examined 3,440 people (2,624 women and 816 men) living in residential or care home. We used four-monthly oral supplementation using 100,000 IU vitamin D₂ (ergocalciferol). As a main outcome measure, we used the incidence of first fracture using an intention to treat analysis. This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales, UK.

Results

The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up (7 fractures per 100 people per year of follow-up), with 218 first fractures in the control group over 2,860 person years of follow-up. The hazard ratio of 0.95 (95% confidence interval 0.79–1.15) for intervention compared to control was not statistically significant.

Conclusion

Supplementation with four-monthly 100,000 IU of oral vitamin D₂ is not sufficient to affect fracture incidence among older people living in institutional care.

Brennan nee Saunders J, Johansen A, Butler J, Stone M, Richmond P, Jones S et al (2003) Place of residence and risk of fracture in older people: a population-based study of over 65-year-olds in Cardiff. Osteoporos Int 14(6):515–519PubMedCrossRef

Chapuy MC, Arlot ME, Duboeuf F, Brun J, Crouzet B, Arnaud S et al (1992) Vitamin D3 and calcium to prevent hip fractures in the elderly women. N Engl J Med 327(23):1637–1642PubMedCrossRef

Lips P, Graafmans WC, Ooms ME, Bezemer PD, Bouter LM (1996) Vitamin D supplementation and fracture incidence in elderly persons. A randomized, placebo-controlled clinical trial. Ann Intern Med 124(4):400–406PubMed

Trivedi DP, Doll R, Khaw KT (2003) 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 326(7387):469PubMedCrossRef

Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T et al (2005) Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. Bmj 330(7498):1003PubMedCrossRef

Grant AM, Avenell A, Campbell MK, McDonald AM, MacLennan GS, McPherson GC et al (2005) Oral vitamin D3 and calcium for secondary prevention of low-trauma fractures in elderly people (Randomised Evaluation of Calcium Or vitamin D, RECORD): a randomised placebo-controlled trial. Lancet 365(9471):1621–1628PubMedCrossRef

Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B (2005) Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. Jama 293(18):2257–2264PubMedCrossRef

Avenell A, Gillespie WJ, Gillespie LD, O’Connell DL (2005) Vitamin D and vitamin D analogues for preventing fractures associated with involutional and post-menopausal osteoporosis. Cochrane Database Syst Rev 3:CD000227PubMed

Law M, Withers H, Morris J, Anderson F (2006) Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in residential accommodation. Age Ageing 35(5):482–486PubMedCrossRef

10.

Lyons RA, Jones S, Kemp A, Sibert J, Shepherd J, Richmond P et al (2002) Development and use of a population based injury surveillance system: the all Wales Injury Surveillance System (AWISS). Inj Prev 8(1):83–86PubMedCrossRef

11.

Brophy S, John G, Evans E, Lyons RA (2005) Methodological issues in the identification of hip fractures using routine hospital data: a database study. Osteoporos Int

12.

Anderson F (2004) Effect of annual intramuscular vitamin D supplementation on fracture risk in 9,440 community living older people: the Wessex Fracture Prevention Trial. ASBMR abstract 1220

13.

Heikinheimo RJ, Inkovaara JA, Harju EJ, Haavisto MV, Kaarela RH, Kataja JM et al (1992) Annual injection of vitamin D and fractures of aged bones. Calcif Tissue Int 51(2):105–110PubMedCrossRef

14.

Flicker L, MacInnis RJ, Stein MS, Scherer SC, Mead KE, Nowson CA et al (2005) Should older people in residential care receive vitamin D to prevent falls? Results of a randomized trial. J Am Geriatr Soc 53(11):1881–1888PubMedCrossRef

15.

Dawson-Hughes B, Harris SS, Krall EA, Dallal GE (1997) Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med 337(10):670–676PubMedCrossRef

16.

Jackson RD, LaCroix AZ, Gass M, Wallace RB, Robbins J, Lewis CE et al (2006) Calcium plus vitamin D supplementation and the risk of fractures. N Engl J Med 354(7):669–683PubMedCrossRef

17.

Boonen S (2006) Fracture risk reduction with vitamin D supplementation requires additional calcium: evidence from a comparative meta-analysis. Osteoporos Int 17(Supp 2):13

18.

Armas LA, Hollis BW, Heaney RP (2004) Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab 89(11):5387–5391PubMedCrossRef

19.

Trang HM, Cole DE, Rubin LA, Pierratos A, Siu S, Vieth R (1998) Evidence that vitamin D3 increases serum 25-hydroxyvitamin D more efficiently than does vitamin D2. Am J Clin Nutr 68(4):854–858PubMed

20.

Harris SS, Dawson-Hughes B, Perrone GA (1999) Plasma 25-hydroxyvitamin D responses of younger and older men to three weeks of supplementation with 1800 IU/day of vitamin D. J Am Coll Nutr 18(5):470–474PubMed

21.

Harris SS, Dawson-Hughes B (2002) Plasma vitamin D and 25OHD responses of young and old men to supplementation with vitamin D3. J Am Coll Nutr 21(4):357–362PubMed

22.

Grey J et al (1998) Secondary prevention of hip fracture: developing a simple protocol for trauma wards. Age Aging 27(Supp 2):19–20

23.

Davies M, Mawer EB, Hann JT, Stephens WP, Taylor JL (1985) Vitamin D prophylaxis in the elderly: a simple effective method suitable for large populations. Age Ageing 14(6):349–354PubMedCrossRef

24.

Stephens WP, Klimiuk PS, Berry JL, Mawer EB (1981) Annual high-dose vitamin D prophylaxis in Asian immigrants. Lancet 2(8257):1199–1202PubMedCrossRef

Title: Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation
Authors: R. A. Lyons
A. Johansen
S. Brophy
R. G. Newcombe
C. J. Phillips
B. Lervy
R. Evans
K. Wareham
M. D. Stone
Publication date: 01-06-2007
Publisher: Springer-Verlag
Published in: Osteoporosis International / Issue 6/2007
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-006-0309-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation

Abstract

Introduction

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 6/2007

Fracture risk and antiresorptive medication use in older women in the USA

Time trends of mortality after first hip fractures

Vitamin D sufficiency: reply to letter by Heaney

Genetic markers for ancestry are correlated with body composition traits in older African Americans

Letter to editor, Osteoporosis International

Osteoclasts prefer aged bone