Title
Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.
Phase
Phase 2Lead Sponsor
SCF PharmaStudy Type
InterventionalStatus
TerminatedIndication/Condition
Cystic FibrosisIntervention/Treatment
efalex ...Study Participants
11Monoglyceride 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 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.
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Inclusion Criteria: forced expiratory volume in 1 second (FEV1) between 30 - 90%. no respiratory exacerbations during the last 2 weeks before the start of the study not have clotting problems or a history of bleeding diathesis patients with liver function abnormalities are included in the study Exclusion Criteria: pregnant women or those not using contraception. known allergy to fish and / or seafood.
