Efficacy of ascorbic acid and N-Acetylcysteine (NAC) supplementation on nutritional, antioxidant status, and respiratory function of male Chronic Obstructive Pulmonary Disease (COPD) patients

ISRCTN	ISRCTN18062761
DOI	https://doi.org/10.1186/ISRCTN18062761
Secondary identifying numbers	UKM 1.5.3.5/244/SPP/NN-056-2009

Submission date: 05/12/2011
Registration date: 20/01/2012
Last edited: 08/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease. It is characterized by a narrowing of the airways in the lungs. There is evidence that an imbalance between oxidants and antioxidants or oxidative stress that may play a role in many of the processes involved in the progress and severity of COPD. These include increased secretion of mucus and increased inflammation in the lungs in response to breathing tobacco smoke. COPD has multiple consequences for the whole body, such as weight loss. It is now thought that oxidative stress may extend beyond the lungs and is involved in these effects. Antioxidant therapy therefore would seem to be a logical treatment approach in COPD. There is a need for more potent antioxidant treatments to test whether antioxidant drugs could be used as a new strategy for the prevention and treatment of COPD. We hope that by doing this study, we will be able to improve nutritional, antioxidant status, and respiratory function in patients suffering from COPD.

Who can participate?
Patients aged between 35 to 75 years old with COPD.

What does the study involve?
Participants will be randomly allocated to one of four groups for 6 months to take one pill daily. Group A will receive vitamin C, group B will receive N-Acetylcysteine (NAC), and the group C will receive both vitamin C and NAC. The control group will not receive any supplements. Weight, height, body mass index, body composition and food intake will be assessed and blood samples will be taken at the start of the study, at month 3 and at month 6. For measuring body composition and blood sampling the patient should fast for at least 8 hours before the procedure. Patients will also undergo breathing tests.

What are the possible benefits and risks of participating?
The research performed will contribute greatly to science and medicine. It will benefit us in terms of understanding further the disease concerned and may help to improve the health status of patients with COPD in the future. There are no additional risks involved and vitamin C and NAC supplementation will not cause any side effects. The dosage used for vitamin C is based on the Recommended Dietary Intake (RDI) for patients and the dosage for NAC is the safety range based on previous studies.

Where is the study run from?
The study takes place at two outpatients departments (OPD) of medical center of Universiti Kebangsaan Malaysia (PPUKM) and Institute of Respiratory Medicine (IPR) in Malaysia.

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between June 2009 and March 2011.

Who is funding the study?
Universiti Kebangsaan Malaysia.

Who is the main contact?
Professor Dr Suzana Shahar
Tel: +60 (0) 3 92897511

Contact information

Ms Elham Pirabbasi
Scientific

Dietetic Programme
Center for Health Care Sciences
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Kuala Lumpur
50300
Malaysia

Study information

Study design	Single-blind randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact Ms. Elham Pirabbasi, el123_2008@yahoo.com to request a patient information sheet
Scientific title	Efficacy of ascorbic acid and/ N-Acetylcysteine (NAC) supplementation on nutritional, antioxidant status, and respiratory function of male Chronic Obstructive Pulmonary Disease (COPD) patients: a randomized controlled trial
Study acronym	COPD
Study objectives	1. Antioxidants (ascorbic acid, glutathione) either alone or in combination had a positive effect after 3 months supplementation on nutritional status among male COPD patients at UKM Medical Centre (PPUKM) and Institute of Respiratory Medicine (Institut Perubatan Respiratori) (IPR) 2. Antioxidants (ascorbic acid, glutathione) either alone or in combination had a positive effect after 3 months supplementation on respiratory function among male COPD patients at PPUKM and IPR 3. Antioxidants (ascorbic acid, glutathione) either alone or in combination had a positive effect after 3 months supplementation on antioxidant and oxidative stress in male patients with COPD at PPUKM and IPR
Ethics approval(s)	ref: UKM 1.5.3.5/244/SPP/NN-056-2009
Health condition(s) or problem(s) studied	Chronic Obstructive Pulmonary Disease
Intervention	Arm A: receive vitamin C supplement (500 mg) effervescent pills orally, once per day for 6 months Arm B: receive NAC (600 mg) effervescent pills orally, once per day for 6 months Arm C: receive combination of both vitamin C (500 mg) and NAC (600 mg) effervescent pills, once per day for 6 months Arm D: control group (not taking placebo), follow-up for 6 months All trial arms will randomly divided and matched for age, gender, smoking index, number of cigarettes (pack year), duration of COPD and family income. Anthropometry measurements, body composition, spirometry and plasma antioxidant and oxidative stress will be assessed for all trial arms before intervention and every 3 months (month 3 and month 6) of the intervention.
Intervention type	Supplement
Primary outcome measure	1. Anthropometry 2. Food record 3. Body composition 4. Spirometry 5. Plasma antioxidants 6. Plasma oxidative stress biomarkers Measured at baseline and every 3 months (month 3 and month 6) of the intervention
Secondary outcome measures	No secondary outcome measures
Overall study start date	24/07/2009
Completion date	15/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	79 subjects participated
Key inclusion criteria	1. An established clinical history of COPD diagnosed by the physician, with pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted 3080%, which was defined as stage I, II and III based on the American Thoracic Society (2004) definition. 2. Patients aged between 35 to 75 years old who did not take any antioxidant supplementation for the past three months, not diagnosed with co-morbidities such as diabetes mellitus (DM), tuberculosis (TB), and inflammatory disease, and had not been hospitalized for the past three months prior to the study
Key exclusion criteria	1. Patients with co-morbidities such as diabetes mellitus (DM), tuberculosis (TB) and inflammatory disease and taking about 500 mg vitamin C through their diet or vitamin C supplements 2. The patients who took drugs such as aspirin, estrogen, amphetamine and cholesyramine regularly for the past three months which affected absorption of vitamin C
Date of first enrolment	24/07/2009
Date of final enrolment	15/03/2011

Locations

Countries of recruitment

Malaysia

Study participating centre

Dietetic Programme

Kuala Lumpur
50300
Malaysia

Sponsor information

National University of Malaysia (Universiti Kebangsaan Malaysia) (Malaysia)
University/education

c/o Prof. Dr. Suzana Shahar
Dietetic Programme
Center for Health Care Sciences
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia

Website	http://www.ukm.my/v3/
"ROR"	https://ror.org/00bw8d226

Funders

Funder type

University/education

National University of Malaysia (Universiti Kebangsaan Malaysia) (Malaysia)
Government organisation / Local government

Alternative name(s): Universiti Kebangsaan Malaysia (UKM), Universiti Kebangsaan Malaysia (UKM), Malaysia, ukminsta, Universiti Kebangsaan Malaysia - UKM, Universiti Kebangsaan Malaysia (Malaysia), University Kebangsaan (Malaysia), UKM
Location: Malaysia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan