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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: MAG-DHA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: forced expiratory volume in 1 second (FEV1) between 30 - 90%. no respiratory exacerbations during the last 2 weeks before the start of the study not have clotting problems or a history of bleeding diathesis patients with liver function abnormalities are included in the study Exclusion Criteria: pregnant women or those not using contraception. known allergy to fish and / or seafood.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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