Elsevier

Maturitas

Volume 65, Issue 4, April 2010, Pages 359-365
Maturitas

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)

https://doi.org/10.1016/j.maturitas.2009.12.018Get rights and content

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 800 IU + calcium carbonate 1000 mg, 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.

Introduction

Each year, one third of individuals aged 65 or older will experience a fall [1]. Fall-related injuries require hospital admission in 42% of cases [2] and 6–23% of those falling suffer serious injuries [3], [4]. The prevention of falls is important for decreasing fracture incidence in the elderly [5].

It is known that low vitamin D status is prevalent in elderly women living in northern latitudes [6] as well as in young adults in northern Europe [7] and in the housebound elderly [8]. Earlier evidence indicates that the risk of falling is associated with poor muscle function attributable to vitamin D deficiency [9], [10]. The mechanism to account for this decrease in falling seems to involve direct effects of vitamin D on neuromuscular function [11], [12], [13] and on balance [14]. Vitamin D combined with calcium is a commonly used form of supplementation. Previous calcium and vitamin D trials on fall and fracture prevention have consisted of ambulatory, community-dwelling or frail nursing home women and the age of the study population and supplementation doses have varied so extensively that comparison between studies is difficult. Therefore, it is not surprising that their outcomes have been conflicting [11], [15], [16]. According to a meta-analysis [17], [18] vitamin D and calcium can reduce the risk of falls in elderly women by more than 20% as well as the risk fractures in older individuals. However, the effect of vitamin D and calcium supplementation on fall prevention in a non-selected postmenopausal population has not been convincingly demonstrated.

This randomized 3-year intervention trial investigated the effect of daily cholecalciferol of 800 IU and calcium carbonate of 1000 mg on falls in general as well as on falls requiring medical attention in a population-based sample of ambulatory women aged 65–71 years from general population. The open-label trial without placebo could demonstrate the effect of the intervention, in comparison with women who simply continue their normal diet perhaps using non-prescription sources of vitamin D and calcium supplementation.

Section snippets

Study design and participants

This study was based on the OSTPRE-FPS (Osteoporosis Risk Factor and Prevention Study—Fracture Prevention Study) which began in 2003 in Kuopio, Finland. The primary aim of the study was to determine whether vitamin D and calcium supplementation would be effective for fall and fracture prevention in postmenopausal women. The Ethics Committee of Kuopio University Hospital approved the OSTPRE-FPS study in October 2001. Written informed consent was collected from the study participants at the

Results

Table 1 shows the baseline characteristics of the entire OSTPRE-FPS study population (n = 3139) and the subsample (n = 593). With the exception of self-assessed physical ability in the subsample, none of the differences of variable distribution was statistically significant at baseline. There were no statistically significant differences in the covariates between the subsample and the rest of the trial population.

Discussion

The hypothesis was that vitamin D and calcium supplementation would be able to decrease falls in general and falls requiring medical attention. The main analysis of this randomized three year trial gave a negative result: the daily treatment with cholecalciferol 800 IU and calcium carbonate 1000 mg supplementation did not decrease the incidence of falls in general. However, this regimen decreased multiple falls requiring medical attention by 28% in the post hoc analyses. In addition, a subsample

Contributors

Author MK had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Authors MT, RH, EA and HK designed the study and directed its implication. Authors MK, KS, LS, RH and HK analysed and interpreted the data. Author KS helped to prepare materials and methods section. Author MK drafted the manuscript. Authors MT, KS, TR, JS, RH, JA, EA and HK made critical revision of the manuscript for the important intellectual

Competing interests

The authors declare that we have no conflict of interest in connection with this paper.

Funding

Supported by Finnish Cultural Foundation (Hulda Tossavainen Foundation) (MK), Sigrid Juselius Foundation (HK), Academy of Finland (JS) and Kuopio University Hospital EVO-grant and Leiras-Nycomed Ltd with calcium and vitamin D supplementation. We thank Ms. Seija Oinonen for technical support, Dr. Ewen MacDonald for linguistic check and local pharmacies for drug delivery. The study result has been presented at the American Society of Bone and Mineral Research Annual Meeting 2007 in Honololulu,

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    Trial Registration: Clinicaltrials.gov Identifier: NCT00592917.

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