Does daily vitamin D 800IU and calcium 1000mg supplementation decrease the risk of falling in ambulatory women aged 65–71 years? A 3-year randomized population-based trial (OSTPRE-FPS)
Received 5 October 2009; received in revised form 26 November 2009; accepted 16 December 2009. published online 31 December 2009.
Abstract
Objective
The hypothesis was that the calcium and vitamin D supplementation prevents falls at the population level.Study design: The OSTPRE-FPS was a randomized population-based open-trial with 3-year follow-up. The supplementation group (n=1566) received daily cholecalciferol 800IU+calcium carbonate 1000mg, while the control group (n=1573) received no supplementation or placebo. A randomly selected subsample of 593 subjects underwent a detailed measurement program including serum 25(OH)D measurements.
Main outcome measure
The occurrence of falls was the primary outcome of the study. The participants in the subsample were telephoned at 4 months intervals and the rest of the trial population was interviewed by phone once a year.
Results
In the entire trial population (ETP), there were 812 women with 1832 falls in the intervention group and 833 women with 1944 falls in the control group (risk ratio was 0.98, 95% CI 0.92–1.05, P=0.160). The supplementation was not associated with single or multiple falls in the ETP. However, in the subsample, multiple fall incidence decreased by 30% (odds ratio (OR) 0.70, 95% CI 0.50–0.97, P=0.034) in the supplementation group. Further, the supplementation decreased the incidence of multiple falls requiring medical attention (OR 0.72, 95% CI 0.53–0.97, P=0.031) in the ETP. The mean compliance in the entire trial population was 78% and in the subsample 79%.
Discussion
Overall, the primary analysis showed no association between calcium and vitamin D supplementation and risk of falls. However, the results of a post hoc analysis suggested that there was a decreased risk of multiple falls requiring medical attention: this finding requires confirmation.
aBone and Cartilage Research Unit, University of Kuopio, Finland
bDepartment of Obstetrics and Gynecology, Kuopio University Hospital, Finland
cDepartment of Orthopaedics, Traumatology and Handsurgery, Kuopio University Hospital, Finland
dDepartment of Internal Medicine, Kuopio University Hospital, Finland
eResearch Institute of Public Health, University of Kuopio, Finland
fDepartment of Physical and Rehabilitation Medicine, Kuopio University Hospital, Finland
gInstitute of Clinical Medicine, Surgery, University of Kuopio, Finland
Corresponding author at: Bone and Cartilage Research Unit, Mediteknia Building, University of Kuopio, P.O. Box 1627, 70211 Kuopio, Finland. Tel.: +358 50 5584698; fax: +358 17 162940.
ABSTRACT