[Effect of calcium and vitamin D in the reduction of falls in the elderly: a randomized trial versus placebo].

BACKGROUND AND OBJECTIVE

Supplements of calcium and vitamin D (Ca/VitD) could help prevent falls, although it is unknown whether the effect differs according to the level of physical activity or baseline 25-OH-vitamin D3. The objective is to determine the effect of Ca/VitD supplements in reducing falls and the musculoskeletal function in elderly over 65 years living in the community, who do not have osteoporosis or vitamin D deficiency.

MATERIAL AND METHOD

Randomized double-blinded clinical trial. A total of 508 patients were selected from 35 Family Medicine consultations. The treatment was administered to 398 subjects (Ca/VitD 188 and placebo 210). The efficacy parameters were: incidence of falls, changes in muscle strength in dominant hand and changes in musculoskeletal function.

RESULTS

The cumulative incidence of falls in the group Ca/VitD was 27.7% (95% confidence interval [95% CI]: 21.0 to 34.3) and 30.5% in the placebo group (95% CI: 24.0 to 36.9) (P=.537). The difference was not significant in the subgroup analysis: male/female, active/inactive physically and level of 25-OH-vitamin D3 higher/less than 32 ng/ml. There was no difference in muscle strength in subjects of both groups. The proportion of adverse effects was higher in the Ca/VitD group (14.4 versus 7.1%, P=.019).

CONCLUSIONS

The results contradict the recommendation to provide supplements, and it is not an effective and well tolerated strategy. Although they may reduce the risk of falls when there are very low levels of vitamin D, the results are unsatisfactory when elders do not have this deficiency, and it is necessary to consider the possibility of adverse effects.