Funded in part by DSM Nutritional Products
Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline: A Randomized Clinical Trial
Bischoff-Ferrari HA, Dawson-Hughes B, Orav EJ, Staehelin HB, Meyer OW, Theiler R, Dick W, Willett WC, Egli A
JAMA internal medicine · 349 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Government
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
- Company
- DSM Nutritional Products
Based on 2 listed funder(s).
Publication
- Published
- 2016-01-12 · JAMA Intern Med · vol. 176 · issue 2 · p. 175
- Publisher
- American Medical Association
- Cited
- 513 citations · more than 100% of similar papers · 58.2× the field average
- Impact
- Top 10% most cited in its field
- References
- 66 works
- Access
- Free to read
- Research areas
- Vitamin D Research Studies · Bone health and osteoporosis research · Exercise and Physiological Responses
- Keywords
- Medicine, Calcifediol, Vitamin D and neurology, Body mass index, vitamin D deficiency, Internal medicine, Vitamin, Clinical endpoint, Randomized controlled trial, Cohort, Physical therapy
- MeSH
- lower extremity, humans, vitamin d deficiency, calcifediol, vitamin d, double-blind method, accidental falls, aged, aged, 80 and over, female, male, mobility limitation
9 authors
From CH, US
- Heike Annette Bischoff-Ferrari · correspondingUniversity of Zurich
- Bess Dawson‐HughesTufts University; Jean Mayer Human Nutrition Research Center on Aging
- Endel John OravHarvard University
- Hannes B. StaehelinUniversity of Basel
- Otto W. MeyerUniversity of Zurich
- Robert TheilerUniversity of Zurich
Abstract
Importance
Vitamin D deficiency has been associated with poor physical performance.
Objective
To determine the effectiveness of high-dose vitamin D in lowering the risk of functional decline.
Design, setting, and participants
One-year, double-blind, randomized clinical trial conducted in Zurich, Switzerland. The screening phase was December 1, 2009, to May 31, 2010, and the last study visit was in May 2011. The dates of our analysis were June 15, 2012, to October 10, 2015. Participants were 200 community-dwelling men and women 70 years and older with a prior fall.
Interventions
Three study groups with monthly treatments, including a low-dose control group receiving 24,000 IU of vitamin D3 (24,000 IU group), a group receiving 60,000 IU of vitamin D3 (60,000 IU group), and a group receiving 24,000 IU of vitamin D3 plus 300 μg of calcifediol (24,000 IU plus calcifediol group).
Main outcomes and measures
The primary end point was improving lower extremity function (on the Short Physical Performance Battery) and achieving 25-hydroxyvitamin D levels of at least 30 ng/mL at 6 and 12 months. A secondary end point was monthly reported falls. Analyses were adjusted for age, sex, and body mass index.
Results
The study cohort comprised 200 participants (men and women ≥ 70 years with a prior fall). Their mean age was 78 years, 67.0% (134 of 200) were female, and 58.0% (116 of 200) were vitamin D deficient (<20 ng/mL) at baseline. Intent-to-treat analyses showed that, while 60,000 IU and 24,000 IU plus calcifediol were more likely than 24,000 IU to result in 25-hydroxyvitamin D levels of at least 30 ng/mL (P = .001), they were not more effective in improving lower extremity function, which did not differ among the treatment groups (P = .26). However, over the 12-month follow-up, the incidence of falls differed significantly among the treatment groups, with higher incidences in the 60,000 IU group (66.9%; 95% CI, 54.4% to 77.5%) and the 24,000 IU plus calcifediol group (66.1%; 95% CI, 53.5%-76.8%) group compared with the 24,000 IU group (47.9%; 95% CI, 35.8%-60.3%) (P = .048). Consistent with the incidence of falls, the mean number of falls differed marginally by treatment group. The 60,000 IU group (mean, 1.47) and the 24,000 IU plus calcifediol group (mean, 1.24) had higher mean numbers of falls compared with the 24,000 IU group (mean, 0.94) (P = .09).
Conclusions and relevance
Although higher monthly doses of vitamin D were effective in reaching a threshold of at least 30 ng/mL of 25-hydroxyvitamin D, they had no benefit on lower extremity function and were associated with increased risk of falls compared with 24,000 IU.
Trial registration
clinicaltrials.gov Identifier: NCT01017354.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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