NCT02518672

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: SCF Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MAG-DHA	MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
DIETARY_SUPPLEMENT	Placebo	Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• Completion: 2016-11-01
• First posted: 2015-08-10
• Last updated: 2017-10-04

Locations

1 site across 1 country: Canada