Does daily vitamin D 800 IU and calcium 1000 mg supplementation decrease the risk of falling in ambulatory women aged 65-71 years? A 3-year randomized population-based trial (OSTPRE-FPS).
OBJECTIVE
The hypothesis was that the calcium and vitamin D supplementation prevents falls at the population level.


METHODS
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.


METHODS
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%.


CONCLUSIONS
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.
Kärkkäinen
Matti K
MK
Bone and Cartilage Research Unit, University of Kuopio, Finland. matti.karkkainen@uku.fi
Tuppurainen
Marjo
M
Salovaara
Kari
K
Sandini
Lorenzo
L
Rikkonen
Toni
T
Sirola
Joonas
J
Honkanen
Risto
R
Arokoski
Jari
J
Alhava
Esko
E
Kröger
Heikki
H
D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D002118:Calcium / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D010349:Patient Compliance; D014807:Vitamin D / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives / Q000097:blood; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects
D014815:Vitamins; D014807:Vitamin D; C104450:25-hydroxyvitamin D; D002118:Calcium