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

Last updated: October 3, 2017
Sponsor: SCF Pharma
Overall Status: Terminated

Phase

2

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT02518672
14-108
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. pregnant women or those not using contraception.

  2. known allergy to fish and / or seafood.

Study Design

Total Participants: 11
Study Start date:
October 01, 2015
Estimated Completion Date:
November 30, 2016

Study 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.

Connect with a study center

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

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