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

October 3, 2017 updated by: SCF Pharma

Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MAG-DHA
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Dietary supplement: MAG-DHA
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo Comparator: Placebo
Placebo (sunflower oil) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung and systemic inflammation measurement
Time Frame: 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
0 and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
follow up of vital signs
Time Frame: 0 and 90 days
weight (Kg)
0 and 90 days
follow up of vital signs
Time Frame: 0 and 90 days
Body Mass Index (BMI, Kg/cm2)
0 and 90 days
follow up of vital signs
Time Frame: 0 and 90 days
Blood Pressure (mmHg)
0 and 90 days
lipid profile
Time Frame: 0 and 90 days
triglycerides (mmol/l)
0 and 90 days
lipid profile
Time Frame: 0 and 90 days
cholesterol (mmol/l)
0 and 90 days
lipid profile
Time Frame: 0 and 90 days
high density lipoprotein (mmol/l)
0 and 90 days
lipid profile
Time Frame: 0 and 90 days
low density lipoprotein (mmol/l)
0 and 90 days
hepatic function
Time Frame: 0 and 90 days
measurement of Alanine aminotransferase (ALT) in plasma (U/l)
0 and 90 days
hepatic function
Time Frame: 0 and 90 days
measurement of Aspartate aminotransferase (AST) in plasma (U/l)
0 and 90 days
hepatic function
Time Frame: 0 and 90 days
measurement of Gamma glutamyl transpeptidase in plasma (U/l)
0 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCF Pharma

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Solutex GC S.L.

Investigators

  • Principal Investigator: André M Cantin, M.D., Centre de recherche du Centre hospitalier Universitaire de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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