Annual high-dose oral vitamin D and falls and fractures in older women: A randomized controlled trial

Sanders, Kerrie M., Stuart, Amanda L., Williamson, Elizabeth J., Simpson, Julie A., Kotowicz, Mark .A, Young, Doris and Nicholson, Geoffrey C. (2010) Annual high-dose oral vitamin D and falls and fractures in older women: A randomized controlled trial. JAMA - Journal of the American Medical Association, 303 18: 1815-1822. doi:10.1001/jama.2010.594

Author Sanders, Kerrie M.
Stuart, Amanda L.
Williamson, Elizabeth J.
Simpson, Julie A.
Kotowicz, Mark .A
Young, Doris
Nicholson, Geoffrey C.
Title Annual high-dose oral vitamin D and falls and fractures in older women: A randomized controlled trial
Journal name JAMA - Journal of the American Medical Association   Check publisher's open access policy
ISSN 0098-7484
Publication date 2010-05-01
Year available 2010
Sub-type Article (original research)
DOI 10.1001/jama.2010.594
Open Access Status Not yet assessed
Volume 303
Issue 18
Start page 1815
End page 1822
Total pages 8
Place of publication Chicago, IL, United States
Publisher American Medical Association
Language eng
Abstract Context: Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor. Objective: To determine whether a single annual dose of 500 000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture. Design, Setting, and Participants: A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008. Intervention: 500 000 IU of cholecalciferol or placebo. Main Outcome Measures: Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels. Results: Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing. Conclusion: Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures.
Keyword Placebo-controlled Trial
D Supplementation
Q-Index Code C1
Q-Index Status Provisional Code
Grant ID 251682
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
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