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Cited by 511Vitamin D Research StudiesNutrition and Health in AgingBone health and osteoporosis research

Monthly High-Dose Vitamin D Treatment for the Prevention of Functional Decline: A Randomized Clinical Trial

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Bischoff-Ferrari, Heike A., Dawson-Hughes, Bess, Orav, E. John, Staehelin, Hannes B., Meyer, Otto W., Theiler, Robert, Dick, Walter, Willett, Walter C. +1 more·2016·JAMA Internal Medicine
DOI 10.1001/jamainternmed.2015.7148
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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.

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  • Frail elderly patients who received 60,000 IU of supplementary vitamin D3 per month had increased risk of falls and fractures compared with patients randomized to 24,000 IU per month after a 12-month follow-up period.

    “Bischoff-Ferrari et al. [75] demonstrated in a randomized clinical trial that frail elderly patients who received 60,000 IU of supplementary vitamin D3 per month had increased risk of falls and fractures than other patients who were randomized to 24,000 IU per month after a 12-month follow-up period.”

    From Novel Insights on Intake of Fish and Prevention of Sarcopenia: All Reasons for an Adequate Consumption (2020) · cites this paper as [75]

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Authors
Bischoff-Ferrari, H. A., Dawson-Hughes, B., Orav, E. J., Staehelin, H. B., Meyer, O. W., Theiler, R., Dick, W., Willett, W. C., & Egli, A.
Affiliations
  • University of Zurich (CH)
  • Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts
  • Harvard University (US)
  • University of Basel (CH)
Corresponding author
Bischoff-Ferrari, Heike A.
ORCID
Venue
JAMA Internal Medicine
Publisher
American Medical Association (AMA)
Published
2016-02-01
Volume
176
Issue
2
Pages
175
ISSN
2168-6106 (ISSN-L)
DOI
10.1001/jamainternmed.2015.7148
OpenAlex
W2200282880
Cited by
511
References
59
Citations by year
2026: 13 · 2025: 22 · 2024: 30 · 2023: 32 · 2022: 37 · 2021: 53 · 2020: 68 · 2019: 61 · 2018: 65 · 2017: 70 · 2016: 57 · 2014: 1 · 2013: 1
FWCI
76.14
Type
journal article
Language
en
Open access
Locations
  • JAMA Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Zurich Open Repository and Archive (University of Zurich) (acceptedVersion)
  • Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
  • Zurich Open Repository and Archive (University of Zurich)
Funders
  • Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
  • DSM Nutritional Products
Topics
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Vitamin D Research Studies
  • Health Sciences › Medicine › Physiology › Nutrition and Health in Aging
  • Health Sciences › Medicine › Orthopedics and Sports Medicine › Bone health and osteoporosis research
Keywords
vitamin D supplementation, functional decline, older adults, vitamin D deficiency, falls, 1,25-dihydroxyvitamin D3, 25-hydroxyvitamin D, lower limb function, physical performance, community-dwelling older adults, fall prevention, Short Physical Performance Battery
MeSH terms
Accidental Falls, Aged, Aged, 80 and over, Calcifediol, Double-Blind Method, Female, Humans, Male, Vitamin D, Vitamin D Deficiency, Lower Extremity, Mobility Limitation

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