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

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
MAG-DHA
Placebo
Sponsored by
SCF Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MAG-DHA

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2015
Last Updated
October 3, 2017
Sponsor
SCF Pharma
Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Solutex GC S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02518672
Brief Title
Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
Acronym
PREMDIC
Official Title
Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCF Pharma
Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Solutex GC S.L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAG-DHA
Arm Type
Active Comparator
Arm Description
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
MAG-DHA
Intervention Description
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Primary Outcome Measure Information:
Title
Lung and systemic inflammation measurement
Description
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
Time Frame
0 and 90 days
Secondary Outcome Measure Information:
Title
follow up of vital signs
Description
weight (Kg)
Time Frame
0 and 90 days
Title
follow up of vital signs
Description
Body Mass Index (BMI, Kg/cm2)
Time Frame
0 and 90 days
Title
follow up of vital signs
Description
Blood Pressure (mmHg)
Time Frame
0 and 90 days
Title
lipid profile
Description
triglycerides (mmol/l)
Time Frame
0 and 90 days
Title
lipid profile
Description
cholesterol (mmol/l)
Time Frame
0 and 90 days
Title
lipid profile
Description
high density lipoprotein (mmol/l)
Time Frame
0 and 90 days
Title
lipid profile
Description
low density lipoprotein (mmol/l)
Time Frame
0 and 90 days
Title
hepatic function
Description
measurement of Alanine aminotransferase (ALT) in plasma (U/l)
Time Frame
0 and 90 days
Title
hepatic function
Description
measurement of Aspartate aminotransferase (AST) in plasma (U/l)
Time Frame
0 and 90 days
Title
hepatic function
Description
measurement of Gamma glutamyl transpeptidase in plasma (U/l)
Time Frame
0 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André M Cantin, M.D.
Organizational Affiliation
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18036797
Citation
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Results Reference
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PubMed Identifier
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Citation
Andersson C, Al-Turkmani MR, Savaille JE, Alturkmani R, Katrangi W, Cluette-Brown JE, Zaman MM, Laposata M, Freedman SD. Cell culture models demonstrate that CFTR dysfunction leads to defective fatty acid composition and metabolism. J Lipid Res. 2008 Aug;49(8):1692-700. doi: 10.1194/jlr.M700388-JLR200. Epub 2008 Apr 25.
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PubMed Identifier
7697269
Citation
Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.
Results Reference
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PubMed Identifier
20638827
Citation
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Results Reference
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Citation
Fortin S, Compositions comprising polyunsaturated fatty acid monoglycerides or derivatives thereof and uses thereof, US819690, 2012, US8222295, 2012.
Results Reference
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Citation
Fortin S, Polyunsaturated fatty acid monoglycerides, derivatives, and uses thereof, CA2672513, 2008, CA2677670, 2010, US8119690, 2011.
Results Reference
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PubMed Identifier
10570187
Citation
Freedman SD, Katz MH, Parker EM, Laposata M, Urman MY, Alvarez JG. A membrane lipid imbalance plays a role in the phenotypic expression of cystic fibrosis in cftr(-/-) mice. Proc Natl Acad Sci U S A. 1999 Nov 23;96(24):13995-4000. doi: 10.1073/pnas.96.24.13995.
Results Reference
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PubMed Identifier
19828687
Citation
Mimoun M, Coste TC, Lebacq J, Lebecque P, Wallemacq P, Leal T, Armand M. Increased tissue arachidonic acid and reduced linoleic acid in a mouse model of cystic fibrosis are reversed by supplemental glycerophospholipids enriched in docosahexaenoic acid. J Nutr. 2009 Dec;139(12):2358-64. doi: 10.3945/jn.109.110999. Epub 2009 Oct 14.
Results Reference
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PubMed Identifier
21057106
Citation
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PubMed Identifier
23092161
Citation
Morin C, Fortin S, Cantin AM, Sirois M, Sirois C, Rizcallah E, Rousseau E. Anti-cancer effects of a new docosahexaenoic acid monoacylglyceride in lung adenocarcinoma. Recent Pat Anticancer Drug Discov. 2013 Sep;8(3):319-34. doi: 10.2174/1574891x113089990032.
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Morin C, Cantin AM, Vezina FA, Fortin S. The Efficacy of MAG-DHA for Correcting AA/DHA Imbalance of Cystic Fibrosis Patients. Mar Drugs. 2018 May 26;16(6):184. doi: 10.3390/md16060184.
Results Reference
derived

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

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