Vitamin C's Antioxidant Effects and COPD Prognosis

NCT06664957 | Not Yet Recruiting

• 1 other identifier: 2024-R064-02
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

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. 1.Whether Vitamin C reduces the frequency of acute COPD exacerbations.
2. 2.Whether Vitamin C improves pulmonary function and health-related quality of life in patients with COPD.
3. 3.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.
4. 4.Report any adverse events or health changes during the trial.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Vitamin C; Antioxidant Effects; Prognosis

Outcome Measures

Primary Outcomes (1)

• Annual Exacerbation Rate

  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.

  12 months

Secondary Outcomes (13)

• 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

Study Arms (2)

Vitamin C group

EXPERIMENTAL

Participants in this group will receive 400 mg of a nutrient supplement (Vitamin C) daily, administered as two 100 mg tablets in the morning and two 100 mg tablets in the evening for 12 months. Vitamin C is provided as a dietary supplement with the goal of supporting antioxidant defense, potentially reducing oxidative stress and improving clinical outcomes in COPD patients. Regular follow-ups will occur every 3 months to monitor exacerbations, quality of life, and safety.

Dietary Supplement: Vitamin C (Ascorbic Acid)

Placebo group

PLACEBO COMPARATOR

Participants in this group will receive a matching placebo, administered as two tablets in the morning and two tablets in the evening for 12 months. The placebo is identical in appearance to the Vitamin C supplement but contains no active ingredients. Follow-up visits will occur every 3 months, identical to the Vitamin C group, to monitor clinical outcomes, quality of life, and safety.

Other: Placebo

Interventions

Vitamin C (Ascorbic Acid) DIETARY_SUPPLEMENT

Participants in this arm will receive 400 mg of Vitamin C, administered as two 100 mg tablets in the morning and two 100 mg tablets in the evening, for a total of 12 months. The intervention aims to support antioxidant defense and improve clinical outcomes in COPD patients.

Vitamin C group

Placebo OTHER

Participants in this group will receive a placebo, identical in appearance to the active nutrient supplement (Vitamin C) tablets, with no active ingredients. The placebo will be administered as two tablets in the morning and two tablets in the evening (four tablets per day) for a duration of 12 months, serving as a control to compare the effects of the active intervention.

Placebo group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Chao Cao

CONTACT

+86-0574-87089878; caocdoctor@163.com

Shiyi He

CONTACT

+86-0574-87089878; shiyihii@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 30, 2024
• Study Start: December 20, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share