VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture

维生素 D 和 OmegA-3 TriaL：对骨骼结构和结构的影响

• 批准号: 8372176
• 负责人: MERYL Susan LEBOFF
• 金额: $ 28.58万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8372176
• 关键词: 25-hydroxyvitamin D; Address; Adult; Affect; Ancillary Study; Architecture; Attention; Biological Markers; Body Composition; Body fat; Body mass index; Bone Density; Bone Resorption; Bone remodeling; Boston; Cardiovascular Diseases; Center for Translational Science Activities; Characteristics; Cholecalciferol; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Cohort Studies; Collagen Type I; Data; Deterioration; Distal; Dose; Elderly; Enrollment; Equilibrium; Fatty Acids; Fatty acid glycerol esters; Finite Element Analysis; Forearm; Fracture; Funding; Gender; Glosso-Sterandryl; Goals; Health; Health Benefit; Height; High Prevalence; High Resolution Computed Tomography; Hip Fractures; Hip region structure; Image; Imaging Techniques; Institute of Medicine (U.S.); Knowledge; Limb structure; Literature; Malignant Neoplasms; Marines; Measurement; Measures; Medical; Obesity; Observational Study; Omega-3 Fatty Acids; Osteocalcin; Osteogenesis; Osteoporosis; Outcome; Participant; Patients; Peripheral; Placebo Control; Placebos; Prevalence; Primary Prevention; Public Health; Race; Radial; Randomized; Randomized Clinical Trials; Recommendation; Recommended Dietary Allowance; Recruitment Activity; Reporting; Research Priority; Resolution; Resources; Roentgen Rays; Role; Safety; Serum; Skin Pigmentation; Structure; Supplementation; Testing; Thick; Tissues; United States; United States National Institutes of Health; Vertebral column; Visit; Vitamin D; Woman; X-Ray Computed Tomography; age related; aged; bone; bone health; bone imaging; bone loss; bone mass; bone strength; bone turnover; cohort; cost effective; design; double-blind placebo controlled trial; efficacy testing; improved; indexing; insight; men; middle age; prevent; protective effect; skeletal; tibia

DESCRIPTION (provided by applicant): There is a high prevalence of inadequate vitamin D levels in the United States. Despite enthusiasm for the use of vitamin D for bone health, there are limited data on the effects of high-dose vitamin D supplements vs. placebo on bone health and body composition outcomes. Previous data support a positive relationship between 25-hydroxyvitamin D [25(OH) D] levels and bone mineral density (BMD). However, results from clinical trials that test vitamin D supplementation alone on areal BMD (aBMD) are sparse and inconsistent, and it is not known whether vitamin D can prevent or reverse the structural deterioration characteristic of osteoporosis. Recent advances in bone imaging make it possible to assess volumetric BMD (vBMD), structure, and micro- architecture non-invasively with high-resolution peripheral computed tomography (HR-pQCT). In addition, observational studies show an inverse relationship between 25(OH) D levels and body mass index (BMI). Since vitamin D is stored in fat, new dual X-ray absorptiometry (DXA) measures of adiposity can advance understanding of this relationship and determine whether or not supplemental vitamin D has effects on body composition. We propose an ancillary study to the NIH-sponsored, Vitamin D and OmegA-3 Trial (VITAL) (U01 CA138962), an ongoing, randomized, double-blind, placebo-controlled trial of vitamin D3 (cholecalciferol, 2000 IU/d) and/or marine omega-3 fatty acids (1 gm/d) in 20,000 men and women, to test the effects of vitamin D3 on BMD, geometry, architecture, and body composition. In a sub-cohort of 600 participants recruited from the NIH-sponsored Clinical and Translational Science Center (CTSC) in Boston, we seek to test the following hypotheses, with measures at baseline and year 2: Aim 1: High-dose vitamin D3 will (a) produce small increases in aBMD at the spine, hip, forearm and total body, as assessed by DXA and (b) improve balance of bone remodeling through decreases in bone turnover; Aim 2: High-dose vitamin D3 will improve: vBMD and bone structure and architecture at the distal radius and tibia, as assessed by HR-pQCT and bone strength estimates; Aim 3: High-dose vitamin D3 will result in lower (a) total body fat and fat mass index (FMI-fat mass/height2) and/or b) regional fat measures, as assessed by DXA. For each Aim, we will determine whether effects vary with (a) baseline 25(OH) D levels, (b) gender, (c) race/skin pigmentation, and (d) BMI or FMI. We will also define how the 25(OH) D levels corresponding to high-dose vitamin D supplementation affects these bone health and body composition outcomes. In order to complete pre-randomization testing in this sub-cohort, it is critical that this ancillary study be undertaken during the CTSC baseline visits, which begin December, 2011 and extend to early 2013. The proposed studies will provide positive or informative negative results about effects of vitamin D3 alone on bone health and body composition, and enhance understanding of the skeletal mechanisms through which vitamin D may affect fracture outcomes evaluated in a separate study (AR060574). Findings from this proposal will fill gaps in knowledge and inform clinical and public health recommendations. PUBLIC HEALTH RELEVANCE: The purported health benefits of vitamin D are receiving wide attention in the medical literature and the popular press. While some data support a benefit of vitamin D on fracture reduction, there is no information on the effects of high-dose vitamin D on bone structure and architecture and the effects of adiposity on these relationships. Findings from these clinical studies including advanced imaging techniques will elucidate the role of vitamin D on bone mass, architecture and body composition in men and women enrolled in the VITAL study.

描述（由申请人提供）：在美国，维生素D水平不足。尽管热情地将维生素D用于骨骼健康，但有关高剂量维生素D补充剂与安慰剂对骨骼健康和身体成分结果的影响的数据有限。先前的数据支持25-羟基维生素D [25（OH）D]水平与骨矿物质密度（BMD）之间的正相关关系。然而，临床试验的结果是，仅在面部BMD（ABMD）上仅测试维生素D的稀疏且不一致，并且尚不清楚维生素D是否可以预防或逆转骨质疏松的结构恶化特征。骨骼成像的最新进展使得使用高分辨率外围计算机断层扫描（HR-PQCT）评估体积BMD（VBMD），结构和微观结构是可能的。此外，观察性研究表明25（OH）D水平与体重指数（BMI）之间存在反比关系。由于维生素D储存在脂肪中，因此新的双X射线吸收法（DXA）的肥胖度量可以提高对这种关系的理解，并确定补充维生素D是否对人体组成有影响。 We propose an ancillary study to the NIH-sponsored, Vitamin D and OmegA-3 Trial (VITAL) (U01 CA138962), an ongoing, randomized, double-blind, placebo-controlled trial of vitamin D3 (cholecalciferol, 2000 IU/d) and/or marine omega-3 fatty acids (1 gm/d) in 20,000 men and women, to test the effects BMD上的维生素D3的几何形状，结构和身体成分。在波士顿的NIH赞助的临床和转化科学中心（CTSC）招募的600名参与者中，我们试图测试以下假设，在基线和第2年进行措施：AIM 1：高剂量的维生素D3 Will（a）在脊柱，hip，hip，borter and borter and borter and Borter（a）中产生小小的增长（A）减少骨转换； AIM 2：高剂量维生素D3将改善：远端半径和胫骨的VBMD以及骨结构和结构，如HR-PQCT和骨强度估计所评估； AIM 3：高剂量维生素D3将导致较低（a）总体脂肪和脂肪质量指数（FMI-FAT质量/高度2）和/或 b）DXA评估的区域脂肪度量。对于每个目标，我们将确定效果是否随（a）基线25（OH）D水平而变化，（b）性别，（c）种族/皮肤色素沉着以及（d）BMI或FMI。我们还将定义与补充高剂量维生素D相对应的25（OH）D水平如何影响这些骨骼健康和身体组成结果。为了完成该亚船类的随机前测试，至关重要的是，在CTSC基线访问期间进行这项辅助研究至关重要，该研究在2011年12月开始，一直延伸至2013年初。拟议的研究将为骨骼健康和骨骼机构的研究范围内的骨骼机制的了解，将为单独进行维生素D3的影响提供积极或信息的负面结果（AR060574）。该提案的发现将填补知识的空白，并为临床和公共卫生建议提供信息。 公共卫生相关性：维生素D所谓的健康益处在医学文献和大众媒体上受到广泛关注。尽管某些数据支持维生素D对减少断裂的好处，但没有有关高剂量维生素D对骨结构和建筑的影响以及肥胖对这些关系的影响的信息。这些临床研究的发现在内，包括先进的成像技术将阐明维生素D对重要研究的男性和女性骨骼，建筑和身体成分的作用。