Randomized controlled trial of Vitamin D supplementation in older people to optimize bone health

Aspray, Terry J., Chadwick, Thomas, Francis, Roger M., McColl, Elaine, Stamp, Elaine, Prentice, Ann, Von Wilamowitz-Moellendorff, Alexander and Schoenmakers, Inez (2019) Randomized controlled trial of Vitamin D supplementation in older people to optimize bone health. American Journal of Clinical Nutrition, 109 (1). pp. 207-217. ISSN 0002-9165

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Background: Vitamin D insufficiency is common in older people and may lead to increased bone resorption, bone loss, and increased falls and fractures. However, clinical trials assessing the effect of vitamin D supplementation on bone mineral density (BMD) have yielded conflicting results. Objectives This study examined the effect of vitamin D supplementation on BMD at the hip, using dual-energy X-ray absorptiometry. Methods: A total of 379 adults aged ≥70 y (48% women; mean age: 75 y) from the northeast of England were randomly allocated to 1 of 3 doses of vitamin D 3 [12,000 international units (IU), 24,000 IU, or 48,000 IU] given once a month. The primary outcome was change in BMD (δBMD) at the hip. Secondary endpoints comprised the dose effects on femoral neck BMD, falls, circulating calciotropic hormones, bone turnover markers, and adverse events. Results: The mean ± SD baseline plasma 25-hydroxyvitamin D [25(OH)D] concentration was 40.0 ± 20.1 nmol/L, which increased after 12 mo to a mean 25(OH)D of 55.9, 64.6, or 79.0 nmol/L for participants receiving a monthly dose of 12,000, 24,000, or 48,000 IU, respectively (P < 0.01 for difference). There was no between-group difference in δBMD. However, parathyroid hormone concentrations decreased in all 3 groups, with a significantly greater decrease in the 48,000-IU group compared with the 12,000-IU group (P < 0.01). There were no differences in any adverse events between groups, with 3 cases of hypercalcemia, none of nephrolithiasis, and 249 falls observed. Conclusions: There was no difference in change in BMD over 12 mo between the 3 doses of vitamin D, suggesting no effect of the intervention or a similar attenuation of the anticipated decrease in BMD over 12 mo. The treatment was safe and effective in increasing plasma 25(OH)D concentrations, with no dose-related adverse events. This trial was registered at the EU Clinical Trials Register (EudraCT 2011-004890-10) and the ISRCTN Registry (ISRCTN35648481).

Item Type: Article
Uncontrolled Keywords: bone mineral density,dual-energy x-ray absorptiometry,older people,randomized controlled trial,vitamin d,medicine (miscellaneous),nutrition and dietetics ,/dk/atira/pure/subjectarea/asjc/2700/2701
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Nutrition and Preventive Medicine
Faculty of Medicine and Health Sciences > Research Groups > Musculoskeletal Medicine
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Depositing User: LivePure Connector
Date Deposited: 25 Apr 2019 13:30
Last Modified: 21 Oct 2022 22:37
URI: https://ueaeprints.uea.ac.uk/id/eprint/70702
DOI: 10.1093/ajcn/nqy280


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