Ignite Creation Date:
2024-05-06 @ 7:19 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02518672
Status:
TERMINATED
Last Update Posted:
2017-10-04
First Post:
2015-08-03
Brief Title:
Pro-resolving Effect of MAG-DHA in Cystic Fibrosis PREMDIC
Sponsor:
SCF Pharma
Organization:
SCF Pharma
Study Overview
Official Title:
Role of DHA Monoglyceride MAG-DHA in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis
Status:
TERMINATED
Status Verified Date:
2017-10
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:
PREMDIC
Brief Summary:
Monoglyceride of DHA DHA-MAG is a lipid compound for which intestinal absorption would increase the ratio DHA arachidonic acid AA and promote the synthesis of specific metabolites involved in the resolution of inflammation
The PREMDIC project initiated at the Centre Hospitalier Universitaire de Sherbrooke is a randomized double-blind study for people with cystic fibrosis CF and aims to evaluate whether daily supplementation monoglyceride of DHA a fatty acid omega-3 family will reduce lung inflammation and improve pulmonary function
The PREMDIC project initiated at the Centre Hospitalier Universitaire de Sherbrooke is a randomized double-blind study for people with cystic fibrosis CF and aims to evaluate whether daily supplementation monoglyceride of DHA a fatty acid omega-3 family will reduce lung inflammation and improve pulmonary function
Detailed Description:
The goal of the study is
To investigate the efficacity of oral administration of MAG-DHA to increase DHA bioavailability and reduce lung inflammation of patients with cystic fibrosis
The specific objectives of the project are
Determine the effect of MAG-DHA on lipid membranes of the blood mononuclear cells
Evaluate the effect of MAG-DHA on lung inflammation determination of Human leukocyte elastase and alpha1 antitrypsin complexes pHLE
For this study 20 cystic fibrosis patients are recruited Patients are divided into 2 groups of 10 and received a daily dose equivalent to 3 g of placebo sunflower oil or MAG-DHA
The project takes place over a period of 3 months and patients must travel to the research center for a total of five visits including recruitment
For the 2 groups DHA ratio AA is measured in membranes of mononuclear cells Forced expiratory volume in 1 second FEV1 is determined and pHLE complexes are detected in plasma as a marker of inflammation
To investigate the efficacity of oral administration of MAG-DHA to increase DHA bioavailability and reduce lung inflammation of patients with cystic fibrosis
The specific objectives of the project are
Determine the effect of MAG-DHA on lipid membranes of the blood mononuclear cells
Evaluate the effect of MAG-DHA on lung inflammation determination of Human leukocyte elastase and alpha1 antitrypsin complexes pHLE
For this study 20 cystic fibrosis patients are recruited Patients are divided into 2 groups of 10 and received a daily dose equivalent to 3 g of placebo sunflower oil or MAG-DHA
The project takes place over a period of 3 months and patients must travel to the research center for a total of five visits including recruitment
For the 2 groups DHA ratio AA is measured in membranes of mononuclear cells Forced expiratory volume in 1 second FEV1 is determined and pHLE complexes are detected in plasma as a marker of inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None