Clinical trial NCT06664957: Vitamin C's Antioxidant Effects and COPD Prognosis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: Vitamin C
Antioxidant Effects
Prognosis
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 650
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. Whether Vitamin C reduces the frequency of acute COPD exacerbations.
2. 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:

1. 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.
2. Report any adverse events or health changes during the trial.


Eligibility criteria: Inclusion Criteria:

1. Age 40-80 years (including 40 and 80).
2. Patients with COPD classified as GOLD stages 2-4:

   Post-bronchodilator FEV1/FVC \< 70% and FEV1 \< 80% of predicted value.
3. 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.
4. 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.

Exclusion Criteria:

1. 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).
2. 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.
3. History of lung resection or expected need for lung volume reduction surgery during the study.
4. Clinically significant abnormalities on chest CT that are not attributable to COPD.
5. 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.
6. 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.
7. Active malignancy: Patients with active cancer will be excluded.
8. Recent Vitamin C use: Patients who have used Vitamin C supplements within the last 4 weeks will be excluded.
9. Diabetes: Patients with poorly controlled diabetes or fasting blood glucose \> 10 mmol/L will be excluded.
10. 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.

Primary outcomes:
measure: Annual Exacerbation Rate
timeFrame: 12 months
Secondary outcomes:
measure: Time to First Exacerbation
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Frequent Exacerbations (≥2 Events/Year)
timeFrame: 12 months
measure: Moderate to Severe COPD Exacerbations
timeFrame: 12 months
measure: Change in the Average Daily Puffs of Rescue Medication
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in COPD Assessment Test (CAT) Score
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Mortality (All-Cause, Cardiovascular, Respiratory)
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Proportion of Days without Rescue Medication Use
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Number of Emergency Visits due to COPD Exacerbations
timeFrame: 3 months, 6 months, 9 months, and 12 months
measure: Number of Hospitalizations due to COPD Exacerbations
timeFrame: 3 months, 6 months, 9 months, and 12 months
measure: Length of Hospital Stay
timeFrame: 3 months, 6 months, 9 months, and 12 months
Other outcomes:
Locations:
Study officials:
References: