COPD (Chronic Obstructive Pulmonary Disease)NCT06664957
Vitamin C's Antioxidant Effects and COPD Prognosis
A study testing Vitamin C (Ascorbic Acid) in people with COPD (Chronic Obstructive Pulmonary Disease), run by Ningbo No. 1 Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Vitamin C (Ascorbic Acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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:
Read more
- 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.
- Being tested
- Vitamin C (Ascorbic Acid), Placebo
- Keywords
- Vitamin C, Antioxidant Effects, Prognosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (13)
Time to First Exacerbation
Time from randomization to the first acute exacerbation of COPD requiring additional treatment or hospitalization.
Measured: 3 months, 6 months, 9 months, 12 months
Frequent Exacerbations (≥2 Events/Year)
The number of patients experiencing two or more acute exacerbations of COPD during the 12-month follow-up period.
Measured: 12 months
Moderate to Severe COPD Exacerbations
The total number of moderate to severe COPD exacerbations, defined by the need for systemic corticosteroids, antibiotics, or hospitalization.
Measured: 12 months
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in COPD Assessment Test (CAT) Score
Assesses the longitudinal change in COPD Assessment Test (CAT) score from baseline, an 8-item patient-reported outcome measure evaluating the impact of COPD on health status. The CAT score ranges from 0 to 40, with higher scores reflecting a more significant health impact and symptom burden due to COPD.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in St. George's Respiratory Questionnaire (SGRQ) Score
Measures the change in total score from baseline on the St. George's Respiratory Questionnaire (SGRQ), a validated health-related quality of life assessment specific to respiratory diseases. The SGRQ score ranges from 0 to 100, where higher scores denote poorer health-related quality of life and greater disease impact.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Hospital Anxiety and Depression Scale (HADS) Score
Evaluates the change from baseline in Hospital Anxiety and Depression Scale (HADS) score. The HADS comprises two 7-item subscales that independently assess anxiety and depression, each subscale scored from 0 to 21. Higher scores on either subscale indicate more severe symptoms of anxiety or depression.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Mortality (All-Cause, Cardiovascular, Respiratory)
All-cause mortality, cardiovascular mortality, and respiratory system mortality during the study period.
Measured: 3 months, 6 months, 9 months, 12 months
Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety of Vitamin C supplementation will be evaluated by monitoring the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as any abnormal laboratory findings. This includes tracking any unexpected health outcomes or complications that may arise during the study.
Measured: 3 months, 6 months, 9 months, 12 months
Proportion of Days without Rescue Medication Use
This outcome measure calculates the proportion of days during the 12-month follow-up period on which participants did not require rescue medication. It reflects the frequency of stable symptom control, with fewer acute episodes necessitating immediate relief.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months
Number of Emergency Visits due to COPD Exacerbations
This outcome measure records the number of emergency visits required due to COPD exacerbations over the study period.
Measured: 3 months, 6 months, 9 months, and 12 months
Number of Hospitalizations due to COPD Exacerbations
This outcome measure records the number of hospital admissions required due to COPD exacerbations.
Measured: 3 months, 6 months, 9 months, and 12 months
Length of Hospital Stay
This outcome measure evaluates the duration of hospital stay (in days) following hospitalization for COPD exacerbations.
Measured: 3 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start20 Dec 2024 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664957
- Sponsor's protocol ID
- 2024-R064-02
- Status last verified
- Dec 2024
- First submitted
- 27 Oct 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06664957
- Acronym / sponsor ID
- 2024-R064-02
- Keywords
- Vitamin C, Antioxidant Effects, Prognosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C group | Experimental | Dietary Supplement: Vitamin C (Ascorbic Acid)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. |
| Placebo group | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C (Ascorbic Acid)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. | Dietary supplement | Vitamin C group |
| PlaceboParticipants 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. | Other | Placebo group |
Primary outcome
Annual Exacerbation Rate
Time frame: 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.
13 secondary outcomes
Time to First Exacerbation
Time frame: 3 months, 6 months, 9 months, 12 months
Frequent Exacerbations (≥2 Events/Year)
Time frame: 12 months
Moderate to Severe COPD Exacerbations
Time frame: 12 months
Change in the Average Daily Puffs of Rescue Medication
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in COPD Assessment Test (CAT) Score
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Mortality (All-Cause, Cardiovascular, Respiratory)
Time frame: 3 months, 6 months, 9 months, 12 months
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 3 months, 6 months, 9 months, 12 months
Proportion of Days without Rescue Medication Use
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months
Number of Emergency Visits due to COPD Exacerbations
Time frame: 3 months, 6 months, 9 months, and 12 months
Number of Hospitalizations due to COPD Exacerbations
Time frame: 3 months, 6 months, 9 months, and 12 months
Length of Hospital Stay
Time frame: 3 months, 6 months, 9 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C (Ascorbic Acid) in people with COPD (Chronic Obstructive Pulmonary Disease), run by Ningbo No. 1 Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Cao (+86-0574-87089878, caocdoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Exacerbation Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.