VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL

VITAL-DEP：维生素 D 和 OmegA-3 试验中的抑郁症终点预防

基本信息

批准号：
8287716
负责人：
Olivia Ifeoma Okereke
金额：
$ 46.86万
依托单位：
BRIGHAM AND WOMEN'S HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-29 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8287716
关键词：
Address Adult Affect African American Age American Ancillary Study Anxiety Biological Assay Biological Markers Blood Boston Cardiovascular Diseases Center for Translational Science Activities Chicago Cholecalciferol Chronic Clinical Clinical Sciences Clinical Trials Comorbidity Data Databases Depressive Syndromes Diagnosis Docosahexaenoic Acids Eicosapentaenoic Acid Elderly Enrollment Fatty Acids Funding Gender Geographic Locations Guidelines Health Benefit Incidence Individual Intake Interview Life Major Depressive Disorder Malignant Neoplasms Marines Measures Medical Mental Depression Mental Health Modality Modification Mood Disorders Moods Nutrient Omega-3 Fatty Acids Parents Participant Persons Pharmaceutical Preparations Physical activity Physiological Placebos Plasma Population Study Prevention Prevention Research Primary Prevention Procedures Public Health Questionnaires Race Randomized Recruitment Activity Recurrence Reducing Agents Risk Risk Factors Running Sample Size Sampling San Francisco Schedule Seasons Secondary Prevention Site Subgroup Supplementation Testing Time United States Centers for Medicare and Medicaid Services United States National Institutes of Health Visit Vitamin D Woman aged burden of illness case control cohort depressive symptoms design disability follow-up functional disability geriatric depression heart disease prevention high risk indicated prevention innovation men prevent public health relevance randomized trial recurrent depression response selective prevention treatment effect universal prevention

项目摘要

DESCRIPTION (provided by applicant): We propose to evaluate the effects of vitamin D3 (1600 IU/day) and omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1g/day) supplements on risk of late-life depression and depressive symptoms in the setting of an NIH-funded large-scale randomized trial, the VITamin D and OmegA-3 TriaL (VITAL, 1 U01 CA 138962). VITAL is a 2x2 factorial RCT designed to evaluate the efficacy of vitamin D3 and marine omega-3 fatty acid supplements in the primary prevention of cardiovascular disease and cancer among 20,000 older U.S. men and women. We will address two primary aims. First, we will test whether vitamin D or omega-3 supplementation reduces incident and recurrent depression rates among all participants in the trial. Cases of depression will be identified using questionnaires and additional data on psychiatric visits, diagnoses, and medications from the Centers for Medicare and Medicaid Services database. Second, we will test whether vitamin D or omega-3 supplementation yields better continuous mood scores on repeated measures over the 5-year study period. In addition, we will address three secondary aims. First, in a substudy of 1,000 high-risk participants, defined as persons with known risk factors for late-life depression (selective prevention) or with subsyndromal depressive symptoms (indicated prevention), we will test whether the agents are effective at reducing risk of depression and at yielding lower depression scores over time. Participants in this substudy will be recruited at four Clinical and Translational Science Center (CTSC) sites across the U.S. (Boston, Chicago, San Francisco, and Houston), and will undergo a psychiatric interview at baseline and at 2 years of follow-up (visits will be matched for season, to avoid seasonal bias for vitamin D). Second, we will address whether African-American race modifies effects of vitamin D supplementation on depression risk and on mood scores in the entire VITAL cohort (African-Americans are disproportionately affected by vitamin D insufficiency). Third, in a nested case-control design, we will assess whether baseline plasma levels of vitamin D and omega-3 fatty acids are related to depression risk, and whether they modify treatment effects. We will also be able to explore additive and/or synergistic effects of the agents, as well as effect modification by age, gender, baseline nutrient levels, baseline medical comorbidity, latitude, and physical activity. In summary, this proposal presents a highly efficient and innovative strategy to evaluate simultaneously the efficacy of vitamin D and omega-3 fatty acid supplementation for universal, selective and indicated prevention of late-life depression, as well as to provide characterization of relevant physiologic parameters that may influence this benefit. We request funds for depression case ascertainment, psychiatric assessments, and assays of pre-randomization blood levels of vitamin D and fatty acids in a nested case-control sample. In order to test our hypotheses and to complete pre- randomization psychiatric assessments, it is critically important and time-sensitive that this ancillary study be undertaken in parallel to the enrollment period for the parent VITAL trial, which is scheduled to begin in 2010. PUBLIC HEALTH RELEVANCE: Biologic and observational evidence supports potential mental health benefits of both vitamin D and marine omega-3 fatty acids. However, it remains unclear whether the use of these supplements can prevent onset of late-life depression or can significantly reduce depressive symptoms in late-life. Findings from this proposed study, conducted within a large clinical trial among U.S. adults aged 60 years and above, will clarify whether vitamin D and/or omega-3 fatty acid supplementation reduces risk of late-life depression and depressive symptoms, and will provide important data that will be applicable to public health and clinical guidelines for both primary and secondary prevention of depression.

描述（由申请人提供）：我们建议评估维生素 D3（1600 IU/天）和 omega-3 脂肪酸（二十碳五烯酸 [EPA] + 二十二碳六烯酸 [DHA]，1g/天）补充剂对晚发风险的影响- 在 NIH 资助的一项大规模随机试验 VITamin D 和 OmegA-3 TriaL (VITAL, 1 U01 CA 138962）。 VITAL 是一项 2x2 析因随机对照试验，旨在评估维生素 D3 和海洋 omega-3 脂肪酸补充剂在 20,000 名美国老年男性和女性心血管疾病和癌症一级预防中的功效。我们将解决两个主要目标。首先，我们将测试补充维生素 D 或 omega-3 是否可以降低试验中所有参与者的抑郁症发病率和复发率。将使用医疗保险和医疗补助服务中心数据库中的调查问卷和有关精神病就诊、诊断和药物的其他数据来识别抑郁症病例。其次，我们将测试维生素 D 或 omega-3 补充剂是否能在 5 年研究期间的重复测量中产生更好的连续情绪得分。此外，我们将解决三个次要目标。首先，在一项包含 1,000 名高风险参与者的亚研究中，这些参与者被定义为具有已知晚年抑郁症危险因素（选择性预防）或具有亚综合征抑郁症状（指示性预防）的人，我们将测试这些药物是否能有效降低患抑郁症的风险。抑郁症并随着时间的推移产生较低的抑郁分数。这项子研究的参与者将在美国的四个临床和转化科学中心 (CTSC) 站点（波士顿、芝加哥、旧金山和休斯顿）招募，并将在基线和 2 年随访时接受精神病学访谈（访问将根据季节进行匹配，以避免维生素 D 的季节性偏差）。其次，我们将讨论非裔美国人种族是否会改变维生素 D 补充剂对整个 VITAL 队列中抑郁风险和情绪评分的影响（非裔美国人受到维生素 D 不足的影响尤为严重）。第三，在巢式病例对照设计中，我们将评估维生素 D 和 omega-3 脂肪酸的基线血浆水平是否与抑郁风险相关，以及它们是否会改变治疗效果。我们还将能够探索药物的累加和/或协同效应，以及根据年龄、性别、基线营养水平、基线医疗合并症、纬度和体力活动进行的效应修改。总之，该提案提出了一种高效且创新的策略，可同时评估维生素 D 和 omega-3 脂肪酸补充剂对于普遍、选择性和指示性预防晚年抑郁症的功效，并提供相关生理参数的表征这可能会影响这一利益。我们请求资金用于抑郁症病例查明、精神病学评估以及嵌套病例对照样本中随机化前血液中维生素 D 和脂肪酸水平的测定。为了检验我们的假设并完成预随机化精神病学评估，这项辅助研究与计划于 2010 年开始的母体 VITAL 试验的入组期同时进行，这一点至关重要且具有时间敏感性。公共健康相关性：生物学和观察证据支持维生素 D 和海洋 omega-3 脂肪酸对心理健康的潜在益处。然而，目前尚不清楚使用这些补充剂是否可以预防晚年抑郁症的发作或可以显着减轻晚年抑郁症状。这项拟议研究是在美国 60 岁及以上成年人中进行的一项大型临床试验，结果将阐明补充维生素 D 和/或 omega-3 脂肪酸是否可以降低晚年抑郁症和抑郁症状的风险，并将提供重要的信息。数据将适用于抑郁症一级和二级预防的公共卫生和临床指南。