Effects of ergocalciferol added to calcium on the risk of falls in elderly high-risk women.

Randomized, placebo-controlled trial in ambulatory, community-dwelling women aged 70 to 90 years in Perth, Australia. Participants were high risk for falls because of a recent fall history and had vitamin D insufficiency; 151 women were assigned to the ergocalciferol group.

The active regimen was ergocalciferol 1000 IU/day added to calcium citrate 1000 mg/day for 1 year. Ergocalciferol or identical placebo was taken with the evening meal; calcium citrate was given as two 250-mg tablets in the morning and two 250-mg tablets with the evening meal. In the ergocalciferol group, 151 participants were randomized in a 1:1 allocation design.

Adding ergocalciferol to calcium reduced falls in this population. At least 1 fall during 1 year occurred in 53.0% of the ergocalciferol group versus 62.9% of controls, with OR 0.61 and 95% CI 0.37-0.99; the adjusted RR was 0.61. Benefit was clearest for first falls in winter or spring, where 25.2% versus 35.8% fell, OR 0.55 (95% CI 0.32-0.96), RR 0.77 (95% CI 0.56-0.98), while summer or autumn showed no clear effect (OR 0.81; 95% CI 0.46-1.42). The intervention also reduced having 1 fall (21.2% vs 33.8%; OR 0.50; 95% CI 0.28-0.88), but not more than 1 fall (OR 0.66; 95% CI 0.41-1.06). No differences were seen in cancer, ischemic heart disease, stroke, constipation, or fracture; one participant had mild asymptomatic hypercalcemia.

The trial was limited to elderly women with prior falls and vitamin D insufficiency in Perth, Australia, so generalizability is narrow. Follow-up was 1 year, seasonal effects may limit consistency across the year, and there was a baseline height difference noted between groups. Ethnicity was not reported, and adverse event data were limited, although serious safety signals were not apparent.