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)
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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Vitamin D supplementation and falls: A trial sequential meta-analysis
2014, The Lancet Diabetes and EndocrinologyCitation Excerpt :12 trials recorded falls daily or weekly,21,24,27,28,30,31,33–35,38,40,41 one trial every 6 weeks,37 and six trials between every 3 and 12 months.23,26,29,32,36,39 Overall, we assessed one trial at high risk of bias,23 eight trials at moderate risk,25,26,29,32,33,36,38,39 and 11 trials at low risk of bias.22,24,27,28,30,31,34,35,37,40,41 16 of 20 trials reported baseline 25-hydroxyvitamin D (25OHD) levels, and in 12 of these 16 trials the average baseline 25OHD was less than 50 nmol/L. 17 of 20 trials reported 25OHD on-treatment, with all trials reporting numerical increases in 25OHD from baseline, and 14 trials reporting 25OHD greater than 50 nmol/L in groups treated with vitamin D (table 1).
Trial Registration: Clinicaltrials.gov Identifier: NCT00592917.