A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,424
- 试验地点
- 1
- 主要终点
- Change in Global Composite Score for Cognitive Decline
研究概览
简要总结
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older participants of VITAL.
详细描述
Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 92 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
干预措施: vitamin D3 (Dietary Supplement)
ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
干预措施: omega-3 fatty acids (fish oil) (Drug)
ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
干预措施: vitamin D3 (Dietary Supplement)
ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
干预措施: Fish oil placebo (Dietary Supplement)
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
干预措施: omega-3 fatty acids (fish oil) (Drug)
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
干预措施: Vitamin D3 placebo (Dietary Supplement)
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
干预措施: Vitamin D3 placebo (Dietary Supplement)
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
干预措施: Fish oil placebo (Dietary Supplement)
结局指标
主要结局
Change in Global Composite Score for Cognitive Decline
时间窗: Change over two assessments (baseline, 2.8 years).
We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.
次要结局
- Change in Episodic Memory Score for Cognitive Decline(Change over two assessments (baseline, 2.8 years))
- Change in Executive Function Score for Cognitive Decline(Change over two assessments (baseline, 2.8 years))
- Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.(Change over two assessments (baseline, 2.8 years))
研究者
Jae Hee Kang
Assistant Professor of Medicine
Brigham and Women's Hospital