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

NCT ID: NCT06439875

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-16
• Study Completion Date: 2026-04-30

Brief Summary

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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

L-arginine (arm 1)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

Patients with a certified diagnosis of COPD and chronic respiratory failure will be randomized in a 1:1 ratio into the interventional arm or the placebo controller arm. All patients will undergo multidisciplinary intensive pulmonary rehabilitation for 28 days. The patients in the interventional group will receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C

Placebo (arm 2)

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Patients in this arm will undergo multidisciplinary intensive pulmonary rehabilitation without any dietary supplementation.

Interventions

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

Patients with a certified diagnosis of COPD and chronic respiratory failure will be randomized in a 1:1 ratio into the interventional arm or the placebo controller arm. All patients will undergo multidisciplinary intensive pulmonary rehabilitation for 28 days. The patients in the interventional group will receive a twice-daily oral supplementation with either a combination of 1.66 g l-arginine plus 500 mg liposomal vitamin C

Intervention Type: DIETARY_SUPPLEMENT

placebo

Patients in this arm will undergo multidisciplinary intensive pulmonary rehabilitation without any dietary supplementation.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera dei Colli

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

mauro maniscalco

Role: PRINCIPAL_INVESTIGATOR

IRCCS Maugeri Telese

Locations

Istituti Clinici Scientifici Maugeri Irccs

Telese Terme, Benevento, Italy

Site Status: RECRUITING

Istituti Clinici Scientifici Maugeri IRCCS

Lumezzane, Brescia, Italy

Site Status: RECRUITING

Istituti Clinici Scientifici Maugeri IRCCS

Bari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mauro Maniscalco

Role: CONTACT

mauro.maniscalco@icsmaugeri.it

+39 0824909350

Pasquale Ambrosino

Role: CONTACT

pasquale.ambrosino@icsmaugeri.it

+39 0824909351

Facility Contacts

Mauro Maniscalco, MD

Role: primary

mauro.maniscalco@icsmaugeri.it

+390824909350

Michele Vitacca, MD

Role: primary

michele.vitacca@icsmaugeri.it

Maria Aliani, MD

Role: primary

maria.aliani@icsmaugeri.it

Other Identifiers

CTSM109-23

Identifier Type: -

Identifier Source: org_study_id