Lung VITamin D and OmegA-3 TriaL (Lung VITAL)

肺维生素 D 和 OmegA-3 试用版（肺 VITAL）

• 批准号: 8073110
• 负责人: DIANE R GOLD
• 金额: $ 77.02万
• 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: 2010-06-01 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8073110
• 关键词: Absenteeism at work; Acute Lung Injury; Adult; Age; American; Ancillary Study; Arachidonic Acids; Asthma; Blood; Breathing; Cardiovascular Diseases; Cause of Death; Cholecalciferol; Chronic Obstructive Airway Disease; Clinical Trials; Collagen; Comorbidity; Consumption; Controlled Clinical Trials; Data; Deep Vein Thrombosis; Diagnosis; Dietary intake; Digestion; Disease; Disease Outcome; Disease Progression; Docosahexaenoic Acids; Dose; Double-Blind Method; Eicosanoids; Eicosapentaenoic Acid; Enrollment; Epidemiologic Studies; Epithelial Cells; Equilibrium; Evaluation; Exposure to; Fatty Acids; Fibroblasts; Fish Oils; Fishes; Forced expiratory volume function; Genetic Polymorphism; Gram-Negative Bacteria; Health; Heart failure; Hormones; Immune; Incidence; Infection; Infectious Lung Disorder; Inflammation; Inflammatory Response; Ingestion; Inhibition of Matrix Metalloproteinases Pathway; Intake; Intervention; Lipoxygenase; Lung; Lung diseases; Malignant Neoplasms; Marines; Modality; Morbidity - disease rate; Mus; Muscle Weakness; Nutrient; Observational Study; Obstruction; Obstructive Lung Diseases; Omega-3 Fatty Acids; Organism; Paper; Parents; Participant; Pathway interactions; Peptides; Phagocytes; Pharmaceutical Preparations; Placebo Control; Placebos; Pneumonia; Positioning Attribute; Prevalence; Primary Cancer Prevention; Production; Public Health; Pulmonary Function Test/Forced Expiratory Volume 1; Race; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research Personnel; Respiratory Tract Infections; Respiratory physiology; Risk; Role; Safety; Schedule; Serum; Skin Pigmentation; Source; Steroids; Sun Exposure; Sunlight; Supplementation; Symptoms; Testing; Therapeutic Effect; Time; United States; Viral; Vitamin D; Vitamin D Deficiency; Vitamin D3 Receptor; Wheezing; Woman; Work; Wound Healing; aged; airway obstruction; airway remodeling; antimicrobial; antimicrobial peptide; cost effective; design; disability; extracellular; fungus; high risk; improved; killings; lipid mediator; men; mortality; nutrition; osteoporosis with pathological fracture; public health relevance; pulmonary function; pulmonary function decline; respiratory; smoking cessation; Absenteeism at work; Acute Lung Injury; Adult; Age; American; Ancillary Study; Arachidonic Acids; Asthma; Blood; Breathing; Cardiovascular Diseases; Cause of Death; Cholecalciferol; Chronic Obstructive Airway Disease; Clinical Trials; Collagen; Comorbidity; Consumption; Controlled Clinical Trials; Data; Deep Vein Thrombosis; Diagnosis; Dietary intake; Digestion; Disease; Disease Outcome; Disease Progression; Docosahexaenoic Acids; Dose; Double-Blind Method; Eicosanoids; Eicosapentaenoic Acid; Enrollment; Epidemiologic Studies; Epithelial Cells; Equilibrium; Evaluation; Exposure to; Fatty Acids; Fibroblasts; Fish Oils; Fishes; Forced expiratory volume function; Genetic Polymorphism; Gram-Negative Bacteria; Health; Heart failure; Hormones; Immune; Incidence; Infection; Infectious Lung Disorder; Inflammation; Inflammatory Response; Ingestion; Inhibition of Matrix Metalloproteinases Pathway; Intake; Intervention; Lipoxygenase; Lung; Lung diseases; Malignant Neoplasms; Marines; Modality; Morbidity - disease rate; Mus; Muscle Weakness; Nutrient; Observational Study; Obstruction; Obstructive Lung Diseases; Omega-3 Fatty Acids; Organism; Paper; Parents; Participant; Pathway interactions; Peptides; Phagocytes; Pharmaceutical Preparations; Placebo Control; Placebos; Pneumonia; Positioning Attribute; Prevalence; Primary Cancer Prevention; Production; Public Health; Pulmonary Function Test/Forced Expiratory Volume 1; Race; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Research Personnel; Respiratory Tract Infections; Respiratory physiology; Risk; Role; Safety; Schedule; Serum; Skin Pigmentation; Source; Steroids; Sun Exposure; Sunlight; Supplementation; Symptoms; Testing; Therapeutic Effect; Time; United States; Viral; Vitamin D; Vitamin D Deficiency; Vitamin D3 Receptor; Wheezing; Woman; Work; Wound Healing; aged; airway obstruction; airway remodeling; antimicrobial; antimicrobial peptide; cost effective; design; disability; extracellular; fungus; high risk; improved; killings; lipid mediator; men; mortality; nutrition; osteoporosis with pathological fracture; public health relevance; pulmonary function; pulmonary function decline; respiratory; smoking cessation

DESCRIPTION (provided by investigator): COPD and pneumonia are among the leading causes of morbidity and mortality in adults 60 years and older, and pneumonia rates are higher for those with COPD. Asthma often coexists with COPD in adults and worsens COPD progression. The current modalities for treatment of 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 modulate inflammation. We have carefully evaluated the dose of each of these supplements to achieve the best balance of efficacy and safety. Observational studies and clinical trials suggest that fish consumption and EPA or DHA may protect against COPD, asthma or pneumonia, but data are not consistent. Thus there is a compelling rationale for a clinical trial to evaluate the potential benefits or risks of vitamin D and marine omega-3 fatty acid supplementation on COPD and asthma exacerbations, airflow obstruction and decline of lung function, and risk of pneumonia. We propose to take advantage of a large-scale randomized clinical trial-the VITamin D and OmegA-3 TriaL (VITAL), whose endpoints are primary prevention of cancer and cardiovascular diseases-to conduct the first major evaluation of the role of vitamin D and long-chain marine omega-3 polyunsaturated fatty acid (eicosapentaenoic acid [EPA] plus docosahexaenoic acid [DHA]) supplementation on obstructive and infectious respiratory disease outcomes. VITAL is a cost-effective, randomized, double-blind, placebo- controlled clinical trial among 20,000 men and women without cancer or CVD at baseline, who are selected on age only (men aged e60 and women aged e65), with an oversampling of blacks. In a 2x2 factorial design, participants will be randomized to moderate-to-high dose vitamin D3 (cholecalciferol; 1600 IU [40 5g]/d) and fish oil (EPA [500 mg/d] + DHA [500 mg/d]) supplements (or placebos) independently. We hypothesize that Vitamin D3 and marine omega-3 fatty acid (EPA+DHA) supplementation will result in reduction of COPD and asthma exacerbations; in reduction in decline of lung function; in improvement of airway obstruction and asthma control; and in reduction of pneumonia in adults. To test our Lung VITAL hypotheses it is essential to complete pre-randomization assessment of baseline respiratory symptom status, COPD and asthma exacerbations in the past year; asthma control and use of controller and rescue medication; pulmonary function; and baseline vitamin D and fatty acid levels. Thus it is critically important that this ancillary study be undertaken in parallel to the enrollment period for the parent VITAL trial (Appendix B), which is scheduled to begin in January 2010. PUBLIC HEALTH RELEVANCE: Chronic obstructive lung disease (COPD) and pneumonia are leading causes of death in United States and world-wide. 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. If vitamin D or marine omega-3 fatty acid supplementation reduce COPD and asthma exacerbations, reduce decline of lung function, improve asthma control and/or reduce pneumonia risk, this would be of great benefit to public health.

描述（由研究人员提供）：COPD和肺炎是60岁及60岁以上成人发病率和死亡率的主要原因之一，患有COPD患者的肺炎率更高。哮喘经常与成人COPD共存，并使COPD进展恶化。 COPD治疗的当前方式有限，维生素D缺乏症的患病率很高。 COPD肺部疾病（COPD，哮喘，气流阻塞）和大多数COPD额外的COPD进展的合并症（例如，呼吸道感染/肺炎，肌肉无力，心脏衰竭）可能会受益于维生素D补充治疗，但需要进行严格的测试。海洋omega-3脂肪酸通过从维生素D到调节炎症的不同途径。我们已经仔细评估了每种补品的剂量，以实现功效和安全性的最佳平衡。观察性研究和临床试验表明，鱼类消耗，EPA或DHA可能会预防COPD，哮喘或肺炎，但数据不一致。因此，临床试验有一个令人信服的理由，以评估维生素D和海洋omega-3脂肪酸对COPD和哮喘加重，气流阻塞和肺功能下降以及肺炎的风险的潜在益处或风险。 We propose to take advantage of a large-scale randomized clinical trial-the VITamin D and OmegA-3 TriaL (VITAL), whose endpoints are primary prevention of cancer and cardiovascular diseases-to conduct the first major evaluation of the role of vitamin D and long-chain marine omega-3 polyunsaturated fatty acid (eicosapentaenoic acid [EPA] plus docosahexaenoic acid [DHA])补充阻塞性和感染性呼吸道疾病结局。 Vital是一项具有成本效益，随机，双盲的，安慰剂控制的临床试验，中有20,000名没有癌症的男性和女性在基线时，仅在年龄（年龄E60岁的男性和E65岁的女性）中被选中，并过分采样黑人。在2x2阶乘设计中，参与者将被随机分为中度至高剂量的维生素D3（胆固醇； 1600 IU [40 5G]/d）和鱼油（EPA [500 mg/d] + DHA [500 mg/d]）补充剂（或余地）。我们假设维生素D3和海洋omega-3脂肪酸（EPA+DHA）的补充将导致COPD和哮喘患病的降低。肺功能下降下降；改善气道阻塞和哮喘控制；并减少成人肺炎。 为了检验我们的肺主义假设，必须在过去一年中完成基线呼吸症状状况，COPD和哮喘患者的基线呼吸症状状态，COPD和哮喘的恶化至关重要。控制和救援药物的哮喘控制和使用；肺功能；和基线维生素D和脂肪酸水平。因此，至关重要的是，这项辅助研究与原定于2010年1月开始的家长生命试验（附录B）并行进行。 公共卫生相关性：慢性阻塞性肺病（COPD）和肺炎是美国和全球范围内的主要死亡原因。 COPD也是一个重要的残疾来源，在患病率上正在增加。大约1400万成人患有哮喘，在美国，每年大约有1200万个失踪日期。在成年人中，COPD和哮喘经常共存。如果补充维生素D或海洋omega-3脂肪酸减少了COPD和哮喘加重，减少肺功能的下降，改善哮喘控制和/或降低肺炎风险，这将对公共卫生有很大的好处。