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Trial record 8 of 10 for:    Alpha-1-proteinase inhibitor AND ELANE

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

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ClinicalTrials.gov Identifier: NCT02518672
Recruitment Status : Terminated
First Posted : August 10, 2015
Last Update Posted : October 4, 2017
Sponsor:
Collaborators:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Solutex (Spain)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Dietary Supplement: MAG-DHA Dietary Supplement: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. follow up of vital signs [ Time Frame: 0 and 90 days ]
    weight (Kg)

  2. follow up of vital signs [ Time Frame: 0 and 90 days ]
    Body Mass Index (BMI, Kg/cm2)

  3. follow up of vital signs [ Time Frame: 0 and 90 days ]
    Blood Pressure (mmHg)

  4. lipid profile [ Time Frame: 0 and 90 days ]
    triglycerides (mmol/l)

  5. lipid profile [ Time Frame: 0 and 90 days ]
    cholesterol (mmol/l)

  6. lipid profile [ Time Frame: 0 and 90 days ]
    high density lipoprotein (mmol/l)

  7. lipid profile [ Time Frame: 0 and 90 days ]
    low density lipoprotein (mmol/l)

  8. hepatic function [ Time Frame: 0 and 90 days ]
    measurement of Alanine aminotransferase (ALT) in plasma (U/l)

  9. hepatic function [ Time Frame: 0 and 90 days ]
    measurement of Aspartate aminotransferase (AST) in plasma (U/l)

  10. hepatic function [ Time Frame: 0 and 90 days ]
    measurement of Gamma glutamyl transpeptidase in plasma (U/l)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518672


Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
SCF Pharma
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Solutex (Spain)
Investigators
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Principal Investigator: André M Cantin, M.D. Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Publications of Results:
Other Publications:
Fortin S, Compositions comprising polyunsaturated fatty acid monoglycerides or derivatives thereof and uses thereof, US819690, 2012, US8222295, 2012.
Fortin S, Polyunsaturated fatty acid monoglycerides, derivatives, and uses thereof, CA2672513, 2008, CA2677670, 2010, US8119690, 2011.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SCF Pharma
ClinicalTrials.gov Identifier: NCT02518672     History of Changes
Other Study ID Numbers: 14-108
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases