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      Effect of High-Dose Vitamin D Supplementation on Volumetric Bone Density and Bone Strength : A Randomized Clinical Trial

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          Abstract

          Few studies have assessed the effects of daily vitamin D doses at or above the tolerable upper intake level for 12 months or greater, yet 3% of US adults report vitamin D intakes of at least 4000 IU per day.

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          Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial.

          Kerrie M Sanders, Amanda L Stuart, Elizabeth J Williamson … (2010)
          Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor. To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture. A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008. 500,000 IU of cholecalciferol or placebo. Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels. Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing. Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures. anzctr.org.au Identifier: ACTRN12605000658617; isrctn.org Identifier: ISRCTN83409867.
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            2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary.

            Alexandra Papaioannou, Suzanne Morin, Angela Cheung … (2010)
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              Effects of vitamin D supplementation on musculoskeletal health: a systematic review, meta-analysis, and trial sequential analysis

              Mark J. Bolland, Andrew Grey, Alison Avenell (2018)
              The effects of vitamin D on fractures, falls, and bone mineral density are uncertain, particularly for high vitamin D doses. We aimed to determine the effect of vitamin D supplementation on fractures, falls, and bone density.
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                Author and article information

                Journal
                Title: JAMA
                Abbreviated Title: JAMA
                Publisher: American Medical Association (AMA)
                ISSN (Print): 0098-7484
                Publication date Created: August 27 2019
                Publication date (Print): August 27 2019
                Volume: 322
                Issue: 8
                Page: 736
                Affiliations
                [1 ]McCaig Institute for Bone and Joint Health, Cumming School of Medicine, University of Calgary, Calgary, Canada
                [2 ]Research Facilitation, Alberta Health Services, Calgary, Canada
                Article
                DOI: 10.1001/jama.2019.11889
                PMC ID: 6714464
                PubMed ID: 31454046
                SO-VID: 49e81dab-5fe2-4b09-8e35-177960ad66f5
                Copyright © © 2019
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