Abstract
ABSTRACTBackgroundVitamin 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.ObjectivesThis study examined the effect of vitamin D supplementation on BMD at the hip, using dual-energy X-ray absorptiometry.MethodsA 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 D3 [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.ResultsThe 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.ConclusionsThere 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).
Highlights
Vitamin D insufficiency is common in older people and may lead to increased bone resorption, bone loss, impairment of muscle function, and an increased risk of falls and fractures
The results of clinical trials assessing the effect of vitamin D supplementation on bone mineral density (BMD), bone loss, falls, and fractures have yielded conflicting results, and, a recent meta-analysis of clinical trials reported a possible relation between vitamin D supplementation and higher BMD at the neck of femur, it suggested that supplementation with vitamin D has a benefit for bone health only in those at risk of vitamin D deficiency [1]
We investigated the effects of supplementation dose on a number of predefined secondary endpoints including change in plasma 25(OH)D [total and calculated free 25(OH)D], parathyroid hormone (PTH), and biochemical markers of bone turnover, as well as the frequency of falls and adverse events
Summary
Vitamin D insufficiency is common in older people and may lead to increased bone resorption, bone loss, impairment of muscle function, and an increased risk of falls and fractures. Clinical trials assessing the effect of vitamin D supplementation on bone mineral density (BMD) have yielded conflicting results. Secondary endpoints comprised the dose effects on femoral neck BMD, falls, circulating calciotropic hormones, bone turnover markers, and adverse events. 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).
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