Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
PREMDIC
Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedOctober 4, 2017
October 1, 2017
5 months
August 3, 2015
October 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
follow up of vital signs
0 and 90 days
follow up of vital signs
0 and 90 days
follow up of vital signs
0 and 90 days
lipid profile
0 and 90 days
lipid profile
0 and 90 days
- +5 more secondary outcomes
Study Arms (2)
MAG-DHA
ACTIVE COMPARATORMAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo
PLACEBO COMPARATORPlacebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant women or those not using contraception.
- known allergy to fish and / or seafood.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCF Pharmalead
- Centre de recherche du Centre hospitalier universitaire de Sherbrookecollaborator
- Solutex GC S.L.collaborator
Study Sites (1)
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (16)
Al-Turkmani MR, Freedman SD, Laposata M. Fatty acid alterations and n-3 fatty acid supplementation in cystic fibrosis. Prostaglandins Leukot Essent Fatty Acids. 2007 Nov-Dec;77(5-6):309-18. doi: 10.1016/j.plefa.2007.10.009. Epub 2007 Nov 26.
PMID: 18036797BACKGROUNDAndersson 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.
PMID: 18441018BACKGROUNDCantin 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.
PMID: 7697269BACKGROUNDDyerberg J, Madsen P, Moller JM, Aardestrup I, Schmidt EB. Bioavailability of marine n-3 fatty acid formulations. Prostaglandins Leukot Essent Fatty Acids. 2010 Sep;83(3):137-41. doi: 10.1016/j.plefa.2010.06.007.
PMID: 20638827BACKGROUNDFortin S, Compositions comprising polyunsaturated fatty acid monoglycerides or derivatives thereof and uses thereof, US819690, 2012, US8222295, 2012.
BACKGROUNDFortin S, Polyunsaturated fatty acid monoglycerides, derivatives, and uses thereof, CA2672513, 2008, CA2677670, 2010, US8119690, 2011.
BACKGROUNDFreedman 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.
PMID: 10570187BACKGROUNDMimoun 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.
PMID: 19828687BACKGROUNDMorin C, Fortin S, Cantin AM, Rousseau E. Docosahexaenoic acid derivative prevents inflammation and hyperreactivity in lung: implication of PKC-Potentiated inhibitory protein for heterotrimeric myosin light chain phosphatase of 17 kD in asthma. Am J Respir Cell Mol Biol. 2011 Aug;45(2):366-75. doi: 10.1165/rcmb.2010-0156OC. Epub 2010 Nov 5.
PMID: 21057106BACKGROUNDMorin 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.
PMID: 23092161BACKGROUNDPanchaud A, Sauty A, Kernen Y, Decosterd LA, Buclin T, Boulat O, Hug C, Pilet M, Roulet M. Biological effects of a dietary omega-3 polyunsaturated fatty acids supplementation in cystic fibrosis patients: a randomized, crossover placebo-controlled trial. Clin Nutr. 2006 Jun;25(3):418-27. doi: 10.1016/j.clnu.2005.10.011. Epub 2005 Dec 2.
PMID: 16325968BACKGROUNDPier G, Prince A, Cantin A. Cystic fibrosis: an-ion transport issue? Nat Med. 2011 Feb;17(2):166-7. doi: 10.1038/nm0211-166.
PMID: 21297610BACKGROUNDVij N, Mazur S, Zeitlin PL. CFTR is a negative regulator of NFkappaB mediated innate immune response. PLoS One. 2009;4(2):e4664. doi: 10.1371/journal.pone.0004664. Epub 2009 Feb 27.
PMID: 19247502BACKGROUNDCantin AM, Bilodeau G, Larivee P, Richter MV. Plasma biomarkers and cystic fibrosis lung disease. Clin Invest Med. 2012 Jul 4;35(4):E173-81. doi: 10.25011/cim.v35i4.17145.
PMID: 22863555RESULTMorin C, Cantin AM, Rousseau E, Sirois M, Sirois C, Rizcallah E, Fortin S. Proresolving Action of Docosahexaenoic Acid Monoglyceride in Lung Inflammatory Models Related to Cystic Fibrosis. Am J Respir Cell Mol Biol. 2015 Oct;53(4):574-83. doi: 10.1165/rcmb.2014-0223OC.
PMID: 25781052RESULTMorin 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.
PMID: 29861448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
André M Cantin, M.D.
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2015
First Posted
August 10, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Study Completion
November 1, 2016
Last Updated
October 4, 2017
Record last verified: 2017-10