Schoenmakers Inez, Francis Roger M, McColl Elaine, Chadwick Thomas, Goldberg Gail R, Harle Christine, Yarnall Alison, Wilkinson Jennifer, Parker Jennie, Prentice Ann, Aspray Terence
MRC Human Nutrition Research, Elsie Widdowson Laboratory, Fulbourn Road, Cambridge CB1 9NL, UK.
Trials. 2013 Sep 17;14:299. doi: 10.1186/1745-6215-14-299.
UNLABELLED: The randomised, double blind intervention trial 'Optimising Vitamin D Status in Older People' (VDOP) will test the effect of three oral dosages of vitamin D given for one year on bone mineral density (BMD) and biochemical markers of vitamin D metabolism, bone turnover and safety in older people. VDOP is funded by Arthritis Research UK, supported through Newcastle University and MRC Human Nutrition Research and sponsored by the Newcastle upon Tyne Hospitals NHS Foundation Trust.a BACKGROUND: Vitamin D insufficiency is common in older people and may lead to secondary hyperparathyroidism, bone loss, impairment of muscle function and increased risk of falls and fractures. Vitamin D supplementation trials have yielded conflicting results with regard to decreasing rates of bone loss, falls and fractures and the optimal plasma concentration of 25 hydroxy vitamin D (25OHD) for skeletal health remains unclear. METHOD/DESIGN: Older (≥70 years) community dwelling men and women are recruited through General Practices in Northern England and 375 participants are randomised to take 12,000 international units (IU), 24,000 IU or 48,000 IU of vitamin D3 orally each month for one year starting in the winter or early spring. Hip BMD and anthropometry are measured at baseline and 12 months. Fasting blood samples are collected at baseline and three-month intervals for the measurement of plasma 25OHD, parathyroid hormone (PTH), biochemical markers of bone turnover and biochemistry to assess the dose-response and safety of supplementation. Questionnaire data include falls, fractures, quality of life, adverse events and outcomes, compliance, dietary calcium intake and sunshine exposure. DISCUSSION: This is the first integrated vitamin D supplementation trial in older men and women using a range of doses given at monthly intervals to assess BMD, plasma 25OHD, PTH and biochemical markers of bone turnover and safety, quality of life and physical performance. We aim to investigate the vitamin D supplementation and plasma 25OHD concentration required to maintain bone health and to develop a set of biochemical markers that reflects the effect of vitamin D on bone. This will aid future studies investigating the effect of vitamin D supplementation on fracture risk.#ISRCTN 35648481 (assigned 16 August 2012), EudraCT 2011-004890-10.
未标注：随机双盲干预试验“优化老年人维生素D状况”（VDOP）将测试三种口服维生素D剂量服用一年对老年人骨矿物质密度（BMD）、维生素D代谢生化标志物、骨转换及安全性的影响。VDOP由英国关节炎研究协会资助，通过纽卡斯尔大学和医学研究委员会人类营养研究中心提供支持，并由泰恩河畔纽卡斯尔国民保健服务基金会信托医院赞助。 背景：维生素D不足在老年人中很常见，可能导致继发性甲状旁腺功能亢进、骨质流失、肌肉功能受损以及跌倒和骨折风险增加。关于减少骨质流失、跌倒和骨折发生率以及骨骼健康所需的最佳血浆25羟维生素D（25OHD）浓度，维生素D补充试验结果相互矛盾。 方法/设计：通过英格兰北部的全科医疗招募年龄较大（≥70岁）的社区居住男性和女性，375名参与者被随机分配，从冬季或早春开始，每月口服12000国际单位（IU）、24000 IU或48000 IU的维生素D3，为期一年。在基线和12个月时测量髋部骨密度和人体测量数据。在基线和每隔三个月采集空腹血样，用于测量血浆25OHD、甲状旁腺激素（PTH）、骨转换生化标志物和生化指标，以评估补充剂的剂量反应和安全性。问卷数据包括跌倒、骨折、生活质量、不良事件及结果、依从性、膳食钙摄入量和阳光照射情况。 讨论：这是首次针对老年男性和女性进行的综合维生素D补充试验，采用每月间隔服用一系列剂量的方式，以评估骨密度、血浆25OHD、PTH以及骨转换生化标志物和安全性、生活质量和身体机能。我们旨在研究维持骨骼健康所需的维生素D补充量和血浆25OHD浓度，并开发一套反映维生素D对骨骼影响的生化标志物。这将有助于未来研究维生素D补充对骨折风险的影响。#国际标准随机对照试验编号35648481（2012年8月16日分配），欧盟临床试验编号2011 - 004890 - 10
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