LungVITamin D and OmegA-3 Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25,871
- 试验地点
- 1
- 主要终点
- COPD exacerbations in the past year over the course of the study
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 25,871 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 reduces respiratory morbidity, including COPD and asthma exacerbations, the risk of pneumonia, and airflow obstruction/decline of pulmonary function; and whether either of these interventions improves asthma control.
详细描述
Chronic obstructive lung disease (COPD) and pneumonia are leading causes of death in United States and worldwide. COPD, which is also a significant source of disability, is increasing in prevalence. Approximately 14 million adults have asthma, which leads to approximately 12 million missed work days per year in the United States. In adults, COPD and asthma often coexist. Treatment options for COPD are limited, and prevalence of vitamin D deficiency is high. COPD lung disease (COPD, asthma, airflow obstruction), and most COPD additional co-morbidities responsible for COPD progression (e.g., respiratory infections/pneumonia, muscle weakness, cardiac failure) may benefit from vitamin D supplementation therapy, but this requires rigorous testing. Marine omega-3 fatty acids work through different pathways from vitamin D to affect inflammation. Observational studies and clinical trials suggest that consumption of fish and/or fish oil may protect against COPD, asthma or pneumonia, but the data are not consistent. Thus, there is a compelling need for a clinical trial to evaluate the potential benefits or risks of vitamin D and fish oil supplementation on COPD and asthma exacerbations, airflow obstruction and decline of lung function, and risk of pneumonia.
The primary outcomes of interest in Lung VITAL are COPD exacerbations; airflow obstruction and decline of pulmonary function; and pneumonia. Asthma exacerbations and asthma control are secondary outcomes. A tertiary goal is to assess whether the effects of the interventions differ by baseline dietary intake or baseline blood levels of the nutrients.
Depending on the primary outcome, Lung VITAL will be conducted among all participants in VITAL (NCT 01169259), or in subsets of the VITAL population who were followed by detailed respiratory questionnaire and/or lung function testing.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study is open to all VITAL participants (NCT 01169259). Population includes men 50 years of age or older and women 55 years of age or older in the United States
- •Participants who live in selected metropolitan areas of the U.S. (where we set up the infrastructure for clinic or home visits), are eligible for pulmonary function measurements.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D3 placebo + fish oil
Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
干预措施: fish oil (Dietary Supplement)
Vitamin D3 placebo + fish oil placebo
Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D3 + fish oil placebo
Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D3 placebo + fish oil
Drug: omega-3 fatty acids (fish oil) Dietary Supplement: vitamin D3 placebo
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D3 placebo + fish oil placebo
Dietary Supplement: vitamin D3 placebo Dietary Supplement: fish oil placebo
干预措施: Fish oil placebo (Dietary Supplement)
Vitamin D3 + fish oil
Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
干预措施: Vitamin D3 (Dietary Supplement)
Vitamin D3 + fish oil
Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil)
干预措施: fish oil (Dietary Supplement)
Vitamin D3 + fish oil placebo
Dietary Supplement: vitamin D3 Dietary Supplement: fish oil placebo
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
COPD exacerbations in the past year over the course of the study
时间窗: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
Baseline respiratory symptom status, respiratory disease diagnoses, and COPD (chronic obstructive pulmonary disease) exacerbations in the past year are measured pre-randomization and annually during follow-up.
Airflow obstruction/change in pulmonary function
时间窗: pre-randomization and after 2 years follow-up
In a sub-group of study participants pulmonary function will be measured pre-randomization and after 2 years of follow-up
Pneumonia in the past year over the course of the study
时间窗: at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year
Pneumonia in the past year (overall and in those with COPD and asthma) is measured pre-randomization and annually during follow-up.
COPD Exacerbations Expressed as Cumulative Rate/Year Over 5 Years
时间窗: 5 years
The primary questionnaire-based outcome was COPD respiratory exacerbations, defined for those with COPD as the number of episodes in the past 12 months of a flare-up of chest trouble treated with additional antibiotic or steroid medication at home, or resulting in hospitalization
Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1))
时间窗: pre-randomization and after 2 years follow-up
In a sub-group of study participants change in pulmonary function (FEV1) will be measured between pre-randomization and 2 years of follow-up
Change Between Pre-randomization and 2-year Follow-up in Level of Measures of Pulmonary Function Representing Air Flow/Airflow Obstruction (Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC))
时间窗: 2 years
In a sub-group of study participants change in pulmonary function (FEV1/FVC) will be measured between pre-randomization and 2 years of follow-up
Pneumonia
时间窗: 5 years
The rate of pneumonia incidence per year
次要结局
- Asthma exacerbations and asthma control in the past year over the course of the study(at baseline (before randomization), 1-year, 2-year, 3-year,4-year, 5-year)
- Asthma Exacerbations Expressed as Cumulative Rate/Year Over 5 Years(5 years)
研究者
Diane Gold
Professor of Medicine
Brigham and Women's Hospital