Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Australia.
Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Clayton, Australia.
J Steroid Biochem Mol Biol. 2019 Feb;186:169-175. doi: 10.1016/j.jsbmb.2018.10.011. Epub 2018 Oct 25.
This randomised placebo-controlled trial aimed to determine the effect of 16-weeks cholecalciferol supplementation on calcium-phosphate homeostasis and bone mineral density (BMD) in overweight and obese adults. Fifty-four vitamin D-deficient (25OHD<50 nmol/L), overweight and obese adults (mean age 32 ± 8.5 years) were included in the trial. Participants were randomly assigned to receive either a bolus oral dose of 100,000 IU cholecalciferol followed by 4000 IU cholecalciferol/d or a matching placebo for 16 weeks. Before and after the intervention, serum calcium, phosphate, 25-hydroxyvitamin D [25(OH)D], intact parathyroid hormone (iPTH) and C-terminal plasma fibroblast growth factor-23 (cFGF-23) concentrations were measured. Whole-body BMD was assessed using dual-energy X-ray absorptiometry (DXA) and diet and sun exposure were assessed using self-administered questionnaires. There were no significant differences in baseline characteristics between the vitamin D and placebo group. After 16-weeks of vitamin D supplementation, mean changes in 25(OH)D concentration were higher in the vitamin D group (57 nmol/L 95% CI 49, 65) compared with placebo (2 nmol/L 95% CI -4, 8), P < 0.001. Additionally, iPTH concentrations declined in the vitamin D group (-1.19 pmol/L 95% CI -1.9, -0.47) compared with placebo (0.14 pmol/L 95% CI -0.49, 0.77), P = 0.006. There were no significant differences in calcium, phosphate, iPTH and cFGF-23 concentrations and whole-body BMD between vitamin D and placebo at follow-up. Inverse correlations were observed between mean change in serum iPTH and cFGF-23 in the vitamin D group only (r=-0.41, P = 0.029). In individuals with greater vitamin D deficiency at baseline (25(OH)D < 30 nmol/L), there was a significant increase in mean whole-body BMD (0.01 g/cm, 95% CI 0.001, 0.025) however, the mean change in BMD was not different between vitamin D and placebo groups in this sub-group analysis. We conclude that cholecalciferol supplementation for 16 weeks increases serum 25(OH)D concentrations and reduces iPTH concentrations in overweight and obese, but otherwise healthy adults with vitamin D deficiency, and has no effect on calcium, phosphate and iFGF-23 concentrations and whole-body BMD.
这项随机安慰剂对照试验旨在确定 16 周胆钙化醇补充对超重和肥胖成年人钙磷稳态和骨密度（BMD）的影响。54 名维生素 D 缺乏症（25OHD<50nmol/L）、超重和肥胖成年人（平均年龄 32±8.5 岁）纳入了该试验。参与者被随机分配接受 100,000IU 胆钙化醇的单次口服剂量，然后每天补充 4000IU 胆钙化醇或接受匹配的安慰剂，为期 16 周。干预前后，测量血清钙、磷、25-羟维生素 D[25(OH)D]、完整甲状旁腺激素（iPTH）和 C 端血浆成纤维细胞生长因子 23（cFGF-23）浓度。使用双能 X 射线吸收法（DXA）评估全身 BMD，使用自我管理问卷评估饮食和阳光暴露。维生素 D 组和安慰剂组在基线特征方面无显著差异。16 周维生素 D 补充后，维生素 D 组 25(OH)D 浓度的平均变化更高（57nmol/L 95%CI 49,65），与安慰剂组（2nmol/L 95%CI-4,8）相比，P<0.001。此外，与安慰剂组（0.14pmol/L 95%CI-0.49,0.77）相比，维生素 D 组 iPTH 浓度下降（-1.19pmol/L 95%CI-1.9,-0.47），P=0.006。随访时，维生素 D 组和安慰剂组之间血清钙、磷、iPTH 和 cFGF-23 浓度和全身 BMD 无显著差异。仅在维生素 D 组中观察到血清 iPTH 和 cFGF-23 的平均变化呈负相关（r=-0.41，P=0.029）。在基线维生素 D 缺乏更严重的个体（25(OH)D<30nmol/L）中，全身 BMD 平均增加（0.01g/cm，95%CI 0.001，0.025），然而，在亚组分析中，维生素 D 组和安慰剂组之间的 BMD 平均变化无差异。我们得出结论，16 周胆钙化醇补充可增加血清 25(OH)D 浓度并降低超重和肥胖但无其他健康问题的维生素 D 缺乏症成年人的 iPTH 浓度，对钙、磷和 iFGF-23 浓度和全身 BMD 无影响。
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