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

NCT06439875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-03-25

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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

OTHER

placebo

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

Sponsors & Collaborators

  • Azienda Ospedaliera dei Colli

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Principal Investigators

  • mauro maniscalco · IRCCS Maugeri Telese

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-16
Primary Completion
2026-02-16
Completion
2026-03-09

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439875 on ClinicalTrials.gov