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

Phase 2

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: MAG-DHA; Dietary Supplement: Placebo

• Registration Number: NCT02518672
• Lead Sponsor: SCF Pharma

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.

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.

Study Timeline

• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-10
• Study Start: 2015-10
• Primary Completion: 2016-03
• Study Completion: 2016-11
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lung and systemic inflammation measurement	0 and 90 days	Docosahexaenoic acid (DHA) and metabolites lipid analyses in plasma and red blood cells Human leukocyte elastase and alpha1 antitrypsin complexes detection in plasma Pulmonary function test (spirometry): Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) Leukocytes differential cell counts and C reactive protein (CRP) determination level in blood

Secondary Outcome Measures

Name	Time	Method
follow up of vital signs	0 and 90 days	Blood Pressure (mmHg)
lipid profile	0 and 90 days	low density lipoprotein (mmol/l)
hepatic function	0 and 90 days	measurement of Gamma glutamyl transpeptidase in plasma (U/l)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada