Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439875
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-28
Brief Title:
Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
Official Title:
Effects of the Association of L-arginine and Liposomal Vitamin C on Fatigue in COPD Patients With Chronic Respiratory Failure After Rehabilitation Intervention
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 ratio to receive a twice-daily oral supplementation with either a combination of 166 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 Students t-test for normally distributed variables or the Mann-Whitney U test for skewed variables
Eligible participants will be randomized using a random number generator in a 11 ratio to receive a twice-daily oral supplementation with either a combination of 166 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 Students t-test for normally distributed variables or the Mann-Whitney U test for skewed variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None