Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States.
Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115, United States; Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, United States.
Contemp Clin Trials. 2018 Apr;67:56-67. doi: 10.1016/j.cct.2018.02.003. Epub 2018 Feb 23.
Vitamin D supplements are often used to benefit skeletal health, although data on effects of daily high-dose vitamin D alone on bone density and structure are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, randomized, placebo-controlled trial testing effects of high-dose supplemental vitamin D (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (FAs; 1 g/day) for the primary prevention of cancer and cardiovascular disease. The study has a mean treatment period of 5 years among 25,874 U.S. men ≥50 years and women ≥55 years old from all 50 states. The ancillary study, VITAL: Effects on Bone Structure and Architecture, is testing effects of vitamin D and/or omega-3 FAs on musculoskeletal outcomes and body composition in a subcohort of 771 participants. At in-person visits at the Harvard Catalyst Clinical and Translational Science Center (CTSC), participants completed bone density/architecture, body composition, and physical performance assessments at baseline and two-year follow-up. Baseline characteristics were evenly distributed among treatment groups, suggesting that any uninvestigated confounders will be evenly distributed; sex differences were also analyzed. Future analyses of the two-year follow-up visits will elucidate whether daily high-dose, supplemental vitamin D and/or omega-3 FAs improve musculoskeletal outcomes, helping to advance clinical and public health recommendations.
NCT01747447.
维生素 D 补充剂常用于促进骨骼健康，但目前缺乏单独使用高剂量维生素 D 对骨密度和结构影响的数据。正在进行的维生素 D 和欧米伽-3 试验（VITAL）是一项双盲、随机、安慰剂对照试验，旨在测试高剂量补充维生素 D（胆钙化醇；2000 IU/天）和/或欧米伽-3 脂肪酸（1 克/天）对癌症和心血管疾病的一级预防作用。该研究在美国 50 个州的 25874 名年龄在 50 岁及以上的男性和 55 岁及以上的女性中进行，平均治疗期为 5 年。辅助研究 VITAL：对骨骼结构和架构的影响，正在测试维生素 D 和/或欧米伽-3 脂肪酸对肌肉骨骼结局和身体成分的影响，研究对象为 771 名参与者的亚队列。在哈佛 Catalyst 临床和转化科学中心（CTSC）的现场访问中，参与者在基线和两年随访时完成了骨密度/结构、身体成分和身体表现评估。基线特征在治疗组之间均匀分布，这表明任何未调查的混杂因素也将均匀分布；还分析了性别差异。对两年随访访问的未来分析将阐明每日高剂量、补充维生素 D 和/或欧米伽-3 脂肪酸是否能改善肌肉骨骼结局，有助于推进临床和公共卫生建议。
NCT01747447。
