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A 3-Year Randomized Controlled Trial

Heike A. Bischoff-Ferrari, MD, MPH; E. John Orav, PhD; Bess Dawson-Hughes, MD

Arch Intern Med. 2006;166:424-430.

Background:  A recent meta-analysis found that cholecalciferol (vitamin D) should reduce falls by more than 20%. However, little is known about whether supplemental cholecalciferol plus calcium citrate malate will lower the long-term risk of falling in men, active older individuals, and older individuals with higher 25-hydroxyvitamin D levels.

Methods:  We studied the effect of 3-year supplementation with cholecalciferol-calcium on the risk of falling at least once in 199 men and 246 women 65 years or older and living at home. Individuals received 700 IU of cholecalciferol plus 500 mg of calcium citrate malate per day or placebo in a randomized double-blind manner. Subjects were classified as less physically active if physical activity was below the median level. Low 25-hydroxyvitamin D levels were classified as those below 32 ng/mL (<80 nmol/L).

Results:  In 3 years, 55% of women and 45% of men reported at least 1 fall. Mean ± SD baseline 25-hydroxyvitamin D levels were 26.6 ± 12.7 ng/mL (66.4 ± 31.7 nmol/L) in women and 33.2 ± 14.2 ng/mL (82.9 ± 34.9) in men. Cholecalciferol-calcium significantly reduced the odds of falling in women (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.30-0.97), but not in men (OR, 0.93; 95% CI, 0.50-1.72). Fall reduction was most pronounced in less active women (OR, 0.35; 95% CI, 0.15-0.81). Baseline 25-hydroxyvitamin D level did not modulate the treatment effect.

Conclusions:  Long-term dietary cholecalciferol-calcium supplementation reduces the odds of falling in ambulatory older women by 46%, and especially in less active women by 65%. Supplementation had a neutral effect in men independent of their physical activity level.

Author Affiliations: Department of Rheumatology and Institute for Physical Medicine, University Hospital Zurich, Zurich, Switzerland (Dr Bischoff-Ferrari); and Departments of Nutrition (Dr Bischoff-Ferrari), Clinical Epidemiology (Dr Orav), and Biostatistics (Dr Orav), Harvard School of Public Health, and Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University (Dr Dawson-Hughes), Boston, Mass.

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