Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation.

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Respiratory Failure; Chronic Obstructive Pulmonary Disease

Treatments: Dietary Supplement: effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06439875

CTSM109-23

Details and patient eligibility

About

The hypothesis that is being tested is that the supplementation of L-arginine plus Vitamin C to multidisciplinary pulmonary rehabilitation (PR) in patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD) and chronic respiratory failure can have a favorable influence on fatigue and on clinical indicators related to endothelial function, potentially mitigating the cardiovascular (CV) disease burden in this clinical context.

Full description

The primary objective of this project is to assess the effects of L-arginine plus Vitamin C supplementation on the physical outcomes in a group of COPD patients with chronic respiratory failure who underwent a 28-day PR program.

Eligible participants will be randomized using a random number generator in a 1:1 ratio to receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C (Bioarginina® C, Farmaceutici Damor, Naples, Italy) or a placebo for 28 days. Vials containing the active supplement or the placebo will be supplied by Farmaceutici Damor and will be made indistinguishable in appearance. All patients will undergo an intensive multidisciplinary PR program based on endurance and strength training. The main outcome of the study is the fatigue severity scale (FSS) total score after rehabilitation. Secondary outcomes include: 6-minute walking distance, forced expiratory volume in the first second (FEV1), COPD assessment test (CAT) score, endothelial function assessed through flow-mediated dilation (FMD), and muscular strength assessed through handgrip measurement.

Anthropometric, clinical, and functional characteristics of the study participants will be reported as mean ± standard deviation (SD) or median (interquartile range, IQR) for continuous variables and as absolute values (percentages) for categorical variables. Changes from baseline for continuous variables will be expressed as deltas (values at 28 days minus the values at baseline), and differences between the interventional groups will be evaluated using the Student's t-test for normally distributed variables or the Mann-Whitney U test for skewed variables.

Enrollment: 102 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD patients of both sexes complicated by respiratory failure (PaO2 inferior to 60 mmHg while breathing room air)
• aged between 40 and 90 years selected from the inpatient/outpatient population admitted to perform a PR program in 12 Italian rehabilitation hospitals.

Exclusion criteria

• consuming any ergogenic supplement in the last 2 months;
• severe acute exacerbations in the 3 months before enrolment;
• clinical instability (pH inferior to 7.35, hemodynamic instability, tachypnea at rest);
• lung restrictive diseases;
• primitive pulmonary hypertension;
• recent lung thromboembolic events;
• orthopaedic clinical conditions interfering with exercise;
• coronary heart disease;
• cardiac failure with reduced ejection fraction;
• major cardiac arrhythmias;
• neuromuscular diseases;
• mini mental state examination (MMSE) <24;
• any prior or current medical problem that would limit the subject participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

L-arginine (arm 1)

Experimental group

Description:

Participants in this arm of the study will have an oral supplementation of l-arginine and liposomial vitamin C on a daily basis for 28 days.

Treatment:

Dietary Supplement: effect of L-arginine and liposomial vitamin C on pulmonary rehabilitation

Placebo (arm 2)

Placebo Comparator group

Description:

This arm will be given a placebo comparator on a daily basis for 28 days.

Treatment:

Other: placebo