Vitamin D and Omega-3 Fatty Acids(VITAL Trial): Effects on Fractures

维生素 D 和 Omega-3 脂肪酸（VITAL 试验）：对骨折的影响

• 批准号: 8528478
• 负责人: MERYL Susan LEBOFF
• 金额: $ 18.53万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-17 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8528478
• 关键词: Address; Age; American; Ancillary Study; Animal Model; Blood; Body Weight decreased; Body mass index; Bone Density; Boston; Center for Translational Science Activities; Chicago; Cholecalciferol; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Clinical assessments; Collection; Data; Docosahexaenoic Acids; Dose; Double-Blind Method; Eicosapentaenoic Acid; Elderly; Elderly man; Elderly woman; Enrollment; Epidemiologic Studies; Fish Oils; Fracture; Funding; Gender; General Population; Health; Health Benefit; High Prevalence; Hip Fractures; Hip region structure; Injury; Knowledge; Marines; Measurement; Measures; Medical Records; Metabolic Bone Diseases; Musculoskeletal; Observational Study; Older Population; Omega-3 Fatty Acids; Osteoporosis; Outcome; Parents; Participant; Patients; Physical Function; Physical activity; Placebo Control; Placebos; Prevention; Primary Prevention; Public Health; Questionnaires; Race; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Reporting; Research Infrastructure; Risk; Roentgen Rays; Role; Running; Sampling; San Francisco; Schedule; Science; Seasons; Site; Skin Pigmentation; Supplementation; Testing; Time; United States; United States National Institutes of Health; Vertebral column; Vitamin D; Woman; age related; aged; base; bone; bone health; bone loss; bone mass; clinical practice; cohort; cost effective; dietary supplements; disorder risk; double-blind placebo controlled trial; fall risk; falls; follow-up; frailty; improved; indexing; men; middle age; nutrient blood level; older women; osteoporosis with pathological fracture; prevent; protective effect; public health relevance; skeletal

DESCRIPTION (provided by applicant): Osteoporotic fractures are major public health problems that have been associated with low vitamin D levels. Previous data strongly suggest that doses of vitamin D = 700 IU/day reduce fractures and possibly falls. Basic and small clinical trials suggest that omega-3 fatty acids may also have beneficial skeletal effects, but effects on fractures are not known. Large primary prevention trials with high daily doses of vitamin D and/or omega-3 fatty acids in general populations (i.e., unselected for disease risk) are lacking. We propose an ancillary study to the VITAL study, a large, randomized, double-blind, placebo-controlled trial of vitamin D (in the form of vitamin D3 [cholecalciferol]) and/or marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements, to advance knowledge and test the effects of vitamin D3 (2000 IU/d) and/or fish oil (EPA+DHA, 1g/d) for primary prevention of fractures, bone loss, falls, and frailty. Growing enthusiasm for supplemental vitamin D to support bone health, and use of fish oil, which may also have skeletal effects, underscores the urgent need for a timely initiation of this ancillary study in conjunction with the newly funded VITAL parent study (U01CA 138962). The proposed ancillary study will include 20,000 women and men (>age 65 and 60, respectively) from the 5-year, NIH-sponsored, parent VITAL trial and a sub-cohort from that trial of 700 participants from Clinical and Translational Science Centers (CTSCs) in Boston, Chicago, Houston, and San Francisco to critically test these hypotheses: Primary Aims: In the VITAL cohort, will vitamin D3 and/or EPA+DHA reduce incident a) total fractures and b) hip or non-vertebral fractures? Secondary Aims: In the CTSC sub-cohort, will vitamin D3 and/or EPA+DHA reduce bone loss of the spine, hip, and total body, as assessed by Dual X-ray Absorptiometry at baseline and year 2 and do effects vary with (a) baseline and follow up blood levels of these nutrients, (b) gender, (c) race/skin pigmentation, and (d) body mass index? Tertiary Aims: In the VITAL cohort, will Vitamin D3 and/or EPA+DHA supplementation a) reduce the risk of falls as assessed by annual questionnaires and b) reduce frailty as determined by the questionnaire- based frailty index? Baseline and follow-up blood collections will be matched for season by month to prevent seasonal bias for vitamin D levels. In order to complete pre-randomization measurements among participants in the CTSC sites, it is essential that this ancillary study be undertaken in parallel to the parent VITAL trial placebo "run-in" to get baseline and follow-up measurements, which is scheduled to begin in mid-2010. This time-sensitive ancillary study will rigorously test the role of these nutritional supplements in improving skeletal health and will provide positive or informative null results on the effects of vitamin D and omega-3 fatty acids on fractures, bone density, falls, and frailty. We expect that findings from this ancillary study will inform clinical practice on whether high daily dose vitamin D and/or fish oil reduces the burden of age-related increases in fractures, which would result in widespread public health benefits.

描述（由申请人提供）：骨质疏松性骨折是与低维生素D水平相关的主要公共卫生问题。先前的数据强烈表明，维生素D = 700 IU/天的剂量减少骨折，可能掉落。基本和小型临床试验表明，omega-3脂肪酸也可能具有有益的骨骼作用，但对裂缝的影响尚不清楚。缺乏大型的初级预防试验，每天的维生素D和/或Omega-3脂肪酸在一般人群中（即未选择疾病风险）。我们向重要研究提出了一项辅助研究，一项大型，随机的，双盲的，安慰剂对照的维生素D试验（以维生素D3的形式（胆固醇酚）的形式）和/或/或海洋omega-3脂肪酸（Eicosapentaenoicain + docosahexaexaenoic Acient and Pastion and vistion and dha] dha] dha] dha] dha] dhaeste dha] （2000 IU/D）和/或鱼油（EPA+DHA，1G/D），用于主要预防骨折，骨质流失，跌倒和脆弱。对补充维生素D的越来越多的热情支持骨骼健康和使用鱼油的使用，这也可能产生骨骼作用，这强调了迫切需要及时启动这项辅助研究，并与新资助的重要父母研究（U01CA 138962）结合使用。拟议的辅助研究将包括5年，NIH赞助的父母生命试验的20,000名男性和男性（分别为65岁和60岁），以及来自临床和翻译科学中心（CTSC）的700名参与者的次数，波士顿，芝加哥，休斯顿，休斯顿和旧金山和旧金山的竞争者： EPA+DHA减少事件a）总骨折和b）髋关节或非椎骨骨折？次要目的：在CTSC亚果园中，维生素D3和/或EPA+DHA会减少脊柱，髋关节和总体的骨骼损失，如基线和2年度双X射线吸收测定法所评估，并且与（A）基线和基线的影响不同，并且在这些营养素的血液水平上有所不同，（B）质量，（B）质量，（C）质量，（c）质量（c）质量（c）质量（c）质量（c）（c）质量（c）（b）质量（D）第三级目的：在重要队列中，维生素D3和/或EPA+DHA补充a）减少每年问卷评估的跌倒风险，而b）减少了基于问卷的脆弱指数确定的脆弱性？基线和随访的血液收集将逐月匹配，以防止维生素D水平的季节性偏见。为了完成CTSC站点参与者之间的随机化测量，至关重要的是，这项辅助研究必须与父级生命试验安慰剂“磨合”并行进行，以获得基线和后续测量，该测量计划于2010年中期开始。这项时间敏感的辅助研究将严格测试这些营养补充剂在改善骨骼健康中的作用，并将为维生素D和omega-3脂肪酸对裂缝，骨密度，掉落和脆弱的效果提供积极或信息的无效结果。我们预计，这项辅助研究的发现将为临床实践提供有关临床实践的信息，即高剂量维生素D和/或鱼油是否减轻了与年龄相关的骨折增加的负担，这将导致广泛的公共卫生益处。