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维生素 D 补充剂不能预防老年黑人女性的骨质流失:一项随机对照试验。

Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss: A Randomized Controlled Trial.

机构信息

Bone Mineral Research Center, New York University (NYU) Winthrop Hospital, Mineola, NY, USA.

出版信息

J Bone Miner Res. 2018 Nov;33(11):1916-1922. doi: 10.1002/jbmr.3521. Epub 2018 Jul 19.

Abstract

Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. A total of 260 healthy black American women, 60 years of age and older were recruited to take part in a two-arm, double-dummy 3-year randomized controlled trial (RCT) of vitamin D versus placebo. The study was conducted in an ambulatory clinical research center. Vitamin D dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX), and bone-specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D was 54.8 ± 16.8 nmol/L. There was no group × time interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (p < 0.001). An equivalency analysis showed that the treatment group was equivalent to the control group. Serum PTH and BSAP declined, with a greater decline of PTH in the treatment group. The rate of bone loss with serum 25(OH)D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the Recommended Dietary Allowance (RDA) of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans. © 2018 American Society for Bone and Mineral Research.

摘要

美国黑人的血清 25(OH)D 水平较低,但骨骼健康状况优于美国白人。关于他们是否应该接受维生素 D 缺乏筛查以及是否需要比医学研究所 (IOM) 推荐的更高的维生素 D 需求存在争议。本试验的目的是确定维生素 D 补充剂是否可以预防老年黑人女性的骨质流失。共招募了 260 名健康的美国黑人女性,年龄在 60 岁及以上,参与了一项为期 3 年的维生素 D 与安慰剂的双臂、双盲随机对照试验 (RCT)。该研究在一个门诊临床研究中心进行。维生素 D 剂量调整为维持血清 25(OH)D 水平高于 75 nmol/L。每 6 个月测量一次骨矿物质密度 (BMD) 和血清甲状旁腺激素 (PTH)、C 端交联肽 (CTX) 和骨特异性碱性磷酸酶 (BSAP)。基线血清 25(OH)D 为 54.8 ± 16.8 nmol/L。任何 BMD 测量均无组间时间交互作用。除了全身和脊柱,所有 BMD 测量的时间都有统计学显著的负效应 (p < 0.001)。等效性分析表明,治疗组与对照组等效。血清 PTH 和 BSAP 下降,治疗组 PTH 下降幅度更大。血清 25(OH)D 水平高于 75 nmol/L 时的骨质流失率与血清 25(OH)D 水平处于推荐膳食允许量 (RDA) 50 nmol/L 时的流失率相当。美国黑人应该像美国白人一样暴露在维生素 D 下。

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