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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02518672

Acronym

PREMDIC

Enrollment

Registered

2015-08-10

Start date

2015-10-31

Completion date

2016-11-30

Last updated

2017-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

DIETARY_SUPPLEMENTMAG-DHA

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

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
follow up of vital signs	0 and 90 days	weight (Kg)
lipid profile	0 and 90 days	triglycerides (mmol/l)
hepatic function	0 and 90 days	measurement of Alanine aminotransferase (ALT) in plasma (U/l)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026