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Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL).
Journal of Bone and Mineral Research ( IF 6.2 ) Pub Date : 2020-01-30 , DOI: 10.1002/jbmr.3958
Meryl S LeBoff 1, 2 , Sharon H Chou 1 , Elle M Murata 1 , Catherine M Donlon 1 , Nancy R Cook 2, 3, 4 , Samia Mora 2, 3, 5 , I-Min Lee 3, 4 , Gregory Kotler 3 , Vadim Bubes 3 , Julie E Buring 2, 3, 4 , JoAnn E Manson 2, 3, 4
Affiliation  

Although supplemental vitamin D is used to promote bone health in the general population, data from randomized controlled trials (RCTs) have been inconsistent. We determined whether daily, vitamin D3 supplementation improves bone mineral density (BMD) and/or structure. VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT of supplemental vitamin D3 (2000 IU/d) and/or omega-3 fatty acids (1 g/d) in 25,871 adults nationwide. This ancillary study included a subcohort of 771 participants (men ≥50 and women ≥55 years; not taking bone active medications) evaluated at baseline and at 2-year follow-up (89% retention). Total 25(OH)D levels were measured by liquid chromatography tandem mass spectrometry (Quest Diagnostics, San Juan Capistrano, CA, USA). Free 25(OH)D (FVD) levels were measured using the ELISA assay by Future Diagnostics Solutions BV (Wijchen, Netherlands). Primary endpoints were 2-year changes in areal (a) BMD at the spine, hip, and whole body determined by dual-energy X-ray absorptiometry (DXA). Secondary endpoints were 2-year changes in volumetric (v) BMD and cortical thickness at the radius and tibia assessed by peripheral quantitative computed tomography. Supplemental vitamin D3 versus placebo had no effect on 2-year changes in aBMD at the spine (0.33% versus 0.17%; p = 0.55), femoral neck (-0.27% versus -0.68%; p = 0.16), total hip (-0.76% versus -0.95%; p = 0.23), or whole body (-0.22% versus -0.15%; p = 0.60), or on measures of bone structure. Effects did not vary by sex, race/ethnicity, body mass index, or 25(OH)D levels. Among participants with baseline FVD levels below the median (<14.2 pmol/L), there was a slight increase in spine aBMD (0.75% versus 0%; p = 0.043) and attenuation in loss of total hip aBMD (-0.42% versus -0.98%; p = 0.044) with vitamin D3 . Whether baseline FVD levels help to identify those more likely to benefit from supplementation warrants further study. Supplemental vitamin D3 versus placebo for 2 years in general healthy adults not selected for vitamin D insufficiency did not improve BMD or structure. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.

中文翻译:

在维生素 D 和 OmegA-3 试验 (VITAL) 中补充维生素 D 对女性和男性骨骼健康结果的影响。

尽管补充维生素 D 用于促进普通人群的骨骼健康,但随机对照试验 (RCT) 的数据并不一致。我们确定每天补充维生素 D3 是否可以改善骨矿物质密度 (BMD) 和/或结构。VITamin D and Omega-3 TriaL (VITAL) 是一项双盲、安慰剂对照的 RCT,研究对象为全国 25,871 名成年人补充维生素 D3(2000 IU/d)和/或 omega-3 脂肪酸(1 g/d)。这项辅助研究包括 771 名参与者(男性≥50 岁和女性 ≥55 岁;未服用骨活性药物)在基线和 2 年随访(89% 保留)时评估的亚组。通过液相色谱串联质谱法(Quest Diagnostics,San Juan Capistrano,CA,USA)测量总 25(OH)D 水平。使用 Future Diagnostics Solutions BV (Wijchen, Netherlands) 的 ELISA 测定法测量游离 25(OH)D (FVD) 水平。主要终点是通过双能 X 射线骨密度仪 (DXA) 确定的脊柱、臀部和全身区域 (a) BMD 的 2 年变化。次要终点是通过外周定量计算机断层扫描评估的桡骨和胫骨的体积 (v) BMD 和皮质厚度的 2 年变化。与安慰剂相比,补充维生素 D3 对脊柱(0.33% 对 0.17%;p = 0.55)、股骨颈(-0.27% 对 -0.68%;p = 0.16)、全髋(- 0.76% 对 -0.95%;p = 0.23),或全身(-0.22% 对 -0.15%;p = 0.60),或骨结构测量。效果不因性别、种族/民族、体重指数或 25(OH)D 水平而异。在基线 FVD 水平低于中位数(<14.2 pmol/L)的参与者中,脊柱 aBMD 略有增加(0.75% 对 0%;p = 0.043)和全髋 aBMD 损失减弱(-0.42% 对 - 0.98%;p = 0.044) 与维生素 D3。基线 FVD 水平是否有助于确定那些更有可能从补充剂中受益的人值得进一步研究。未因维生素 D 不足而选择的一般健康成人 2 年补充维生素 D3 与安慰剂相比,并未改善 BMD 或结构。© 2020 作者。美国骨与矿物质研究学会出版的骨与矿物质研究杂志。基线 FVD 水平是否有助于确定那些更有可能从补充剂中受益的人值得进一步研究。未因维生素 D 不足而选择的一般健康成人 2 年补充维生素 D3 与安慰剂相比,并未改善 BMD 或结构。© 2020 作者。美国骨与矿物质研究学会出版的骨与矿物质研究杂志。基线 FVD 水平是否有助于确定那些更有可能从补充剂中受益的人值得进一步研究。未因维生素 D 不足而选择的一般健康成人 2 年补充维生素 D3 与安慰剂相比,并未改善 BMD 或结构。© 2020 作者。美国骨与矿物质研究学会出版的骨与矿物质研究杂志。
更新日期:2020-01-30
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