NCT06664957尚未招募不适用
The Role of the Antioxidant Effects of Vitamin C in Improving the Prognosis of Patients With Chronic Obstructive Pulmonary Disease: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study.
Ningbo No. 1 Hospital0 个研究点目标入组 650 人开始时间: 2024年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 650
- 主要终点
- Annual Exacerbation Rate
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of Vitamin C supplementation in improving the prognosis of patients with Chronic Obstructive Pulmonary Disease (COPD) through its antioxidant effects.
The primary objectives of the study are to determine:
- Whether Vitamin C reduces the frequency of acute COPD exacerbations.
- Whether Vitamin C improves pulmonary function and health-related quality of life in patients with COPD.
The study will compare Vitamin C to a placebo to assess its impact on oxidative stress and its potential to enhance clinical outcomes in COPD management.
Participants will:
- Receive either daily oral Vitamin C supplementation or a placebo for a period of 6 months. Undergo monthly clinical evaluations, including spirometry and symptom assessments.
- Report any adverse events or health changes during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years (including 40 and 80).
- •Patients with COPD classified as GOLD stages 2-4:
- •Post-bronchodilator FEV1/FVC < 70% and FEV1 < 80% of predicted value.
- •No respiratory infection or acute exacerbation of COPD within 4 weeks prior to enrollment. Acute exacerbation is defined as an acute worsening of respiratory symptoms requiring additional treatment.
- •The patient voluntarily consents to participate in the study, is capable of verbal or written communication, and can understand and sign the informed consent form. The patient must also be able to complete the necessary assessments required for the study.
排除标准
- •Presence of other respiratory diseases such as alpha-1 antitrypsin deficiency, primary ciliary dyskinesia, active pulmonary infection (e.g., tuberculosis), lung cancer, pulmonary fibrosis, cystic fibrosis, obesity hypoventilation syndrome, sarcoidosis, pulmonary hypertension, or clinically significant interstitial lung disease (patients with COPD as the primary disease and comorbid bronchiectasis may be included).
- •History of asthma or asthma-COPD overlap syndrome: Patients currently diagnosed with asthma, according to GINA or other recognized guidelines, will be excluded. Patients with a childhood history of asthma (defined as diagnosis before age 18 and fully resolved) may be included.
- •History of lung resection or expected need for lung volume reduction surgery during the study.
- •Clinically significant abnormalities on chest CT that are not attributable to COPD.
- •Presence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, genitourinary, musculoskeletal, dermatological, sensory, endocrine diseases, or hematological abnormalities, as judged by the investigator, that may affect patient safety or confound the effectiveness or safety analysis during the study.
- •Unstable cardiac disease: Patients will be excluded if they have any of the following conditions: a. Myocardial infarction, unstable angina/acute coronary syndrome, coronary artery bypass graft (CABG) surgery, or percutaneous coronary intervention (PCI) within the past 6 months. b. Structural heart disease such as hypertrophic cardiomyopathy or significant valvular disease. c. Unstable or life-threatening arrhythmias requiring intervention within the past 3 months. d. NYHA class II-IV heart failure.
- •Active malignancy: Patients with active cancer will be excluded.
- •Recent Vitamin C use: Patients who have used Vitamin C supplements within the last 4 weeks will be excluded.
- •Diabetes: Patients with poorly controlled diabetes or fasting blood glucose > 10 mmol/L will be excluded.
- •History of kidney stones or diagnosis of kidney stones within the past year, as high doses of Vitamin C may increase the risk of stone formation.
结局指标
主要结局
Annual Exacerbation Rate
时间窗: 12 months
Annual exacerbation rate will be measured as the total number of acute exacerbations of COPD experienced by each patient during the 12-month follow-up period. An exacerbation is defined as a worsening of COPD symptoms requiring additional treatment or hospitalization.
次要结局
- Time to First Exacerbation(3 months, 6 months, 9 months, 12 months)
- Frequent Exacerbations (≥2 Events/Year)(12 months)
- Moderate to Severe COPD Exacerbations(12 months)
- Change in the Average Daily Puffs of Rescue Medication(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in COPD Assessment Test (CAT) Score(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in St. George's Respiratory Questionnaire (SGRQ) Score(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in Hospital Anxiety and Depression Scale (HADS) Score(Baseline, 3 months, 6 months, 9 months, 12 months)
- Mortality (All-Cause, Cardiovascular, Respiratory)(3 months, 6 months, 9 months, 12 months)
- Adverse Events (AEs) and Serious Adverse Events (SAEs)(3 months, 6 months, 9 months, 12 months)
- Proportion of Days without Rescue Medication Use(Baseline, 3 months, 6 months, 9 months, 12 months)
- Number of Emergency Visits due to COPD Exacerbations(3 months, 6 months, 9 months, and 12 months)
- Number of Hospitalizations due to COPD Exacerbations(3 months, 6 months, 9 months, and 12 months)
- Length of Hospital Stay(3 months, 6 months, 9 months, and 12 months)
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