Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation.
BACKGROUND
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 D(2) (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.


CONCLUSIONS
Supplementation with four-monthly 100,000 IU of oral vitamin D(2) is not sufficient to affect fracture incidence among older people living in institutional care.
Lyons
R A
RA
School of Medicine, University of Wales Swansea, Singleton Park, SA2 8PP, Swansea, UK. r.a.lyons@swansea.ac.uk
Johansen
A
A
Brophy
S
S
Newcombe
R G
RG
Phillips
C J
CJ
Lervy
B
B
Evans
R
R
Wareham
K
K
Stone
M D
MD
D000368:Aged; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004872:Ergocalciferols / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D050723:Fractures, Bone / Q000209:etiology / Q000517:prevention & control*; D006707:Homes for the Aged; D006801:Humans; D008297:Male; D009735:Nursing Homes; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy; D016019:Survival Analysis; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D004872:Ergocalciferols