Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)

SCF Pharma

Status and phase: Terminated; Phase 2

Conditions: Cystic Fibrosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: MAG-DHA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02518672

14-108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. forced expiratory volume in 1 second (FEV1) between 30 - 90%.
2. no respiratory exacerbations during the last 2 weeks before the start of the study
3. not have clotting problems or a history of bleeding diathesis
4. patients with liver function abnormalities are included in the study

Exclusion criteria

1. pregnant women or those not using contraception.
2. known allergy to fish and / or seafood.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups, including a placebo group

MAG-DHA

Active Comparator group

Description:

MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.

Treatment:

Dietary Supplement: MAG-DHA

Placebo

Placebo Comparator group

Description:

Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.

Treatment:

Dietary Supplement: Placebo