Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
NCT ID: NCT02518672
Last Updated: 2017-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2015-10-31
2016-11-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MAG-DHA
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
MAG-DHA
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Interventions
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MAG-DHA
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Eligibility Criteria
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Inclusion Criteria
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
2. known allergy to fish and / or seafood.
18 Years
ALL
No
Sponsors
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Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Solutex GC S.L.
INDUSTRY
SCF Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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André M Cantin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Locations
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Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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References
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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.
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.
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.
Dyerberg 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.
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.
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.
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.
Morin 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.
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.
Panchaud 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.
Pier G, Prince A, Cantin A. Cystic fibrosis: an-ion transport issue? Nat Med. 2011 Feb;17(2):166-7. doi: 10.1038/nm0211-166.
Vij 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.
Cantin 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.
Morin 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.
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.
Other Identifiers
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14-108
Identifier Type: -
Identifier Source: org_study_id