VITAMIN-D SUPPLEMENTATION AND FRACTURE INCIDENCE IN ELDERLY PERSONS -A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL-TRIAL

Objective: To determine whether vitamin D supplementation decreases th e incidence of hip fractures and other peripheral bone fractures. Desi gn: Prospective, double-blind trial. Setting: Community setting (Amste rdam and surrounding area). Patients: 2578 persons (1916 women, 662 me n) 70 years of age and older (mean age +/- SD, 80 +/- 6 years) living independently, in apartments for elderly persons, or in homes for elde rly persons. Intervention: Participants were randomly assigned to rece ive either vitamin D-3, 400 IU in one tablet daily, or placebo for a m aximum of 3.5 years. Measurements: Dietary calcium intake and serum 25 -hydroxyvitamin D [25(OH)D] were estimated in a subset of participants . During follow-up, attention was concentrated on hip fractures and ot her peripheral fractures. The maximal follow-up period was 4 years. Th e results were evaluated by survival analysis. Results: Mean dietary c alcium intake from dairy products was 868 mg/d. Mean serum 25(OH)D con centration in the third year of the study was 23 nmol/L in the placebo group and 60 nmol/L in the vitamin D group. Median follow-up was 3.5 years, and total follow-up was 8450 patient-years. During follow-up, 3 06 persons in the placebo group and 282 persons in the vitamin D group died (P = 0.20). Hip fractures occurred in 48 persons in the placebo group and 58 persons in the vitamin D group (P = 0.39, intention-to-tr eat analysis). Other peripheral fractures occurred in 74 persons in th e placebo group and 77 persons in the vitamin D group (P = 0.86). Conc lusion: Our results do not show a decrease in the incidence of hip fra ctures and other peripheral fractures in Dutch elderly persons after v itamin D supplementation.