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Vitamin C's Antioxidant Effects and COPD Prognosis

ConditionCOPD (Chronic Obstructive Pulmonary Disease)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorNingbo No. 1 Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 40-80 years (including 40 and 80).

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Other intervention

    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.

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Vitamin C groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Time to First Exacerbation

Time from randomization to the first acute exacerbation of COPD requiring additional treatment or hospitalization.

Time frame
3 months, 6 months, 9 months, 12 months
2

Frequent Exacerbations (≥2 Events/Year)

The number of patients experiencing two or more acute exacerbations of COPD during the 12-month follow-up period.

Time frame
12 months
3

Moderate to Severe COPD Exacerbations

The total number of moderate to severe COPD exacerbations, defined by the need for systemic corticosteroids, antibiotics, or hospitalization.

Time frame
12 months
4

Change in the Average Daily Puffs of Rescue Medication

This outcome measure assesses the change from baseline in the average number of daily puffs of rescue medication (e.g., short-acting bronchodilators) used by participants. It serves as an indicator of changes in symptom control and the need for immediate symptom relief throughout the study duration.

Time frame
Baseline, 3 months, 6 months, 9 months, 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ningbo No. 1 Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: