Cystic FibrosisPhase 2PREMDICNCT02518672

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

A Phase 2 study testing MAG-DHA in people with Cystic Fibrosis, run by SCF Pharma at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cystic Fibrosis
What is being tested?: MAG-DHA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteCanada
Study dates: Oct 2015to Nov 2016
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

pregnant women or those not using contraception.
known allergy to fish and / or seafood.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Cystic Fibrosis
Being tested: MAG-DHA, Placebo
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MAG-DHADietary supplement
MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
PlaceboDietary supplement
Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.

Study groups in NCT02518672
Study group	Role	What they receive
MAG-DHA	Active comparator	MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days. Receives: Dietary Supplement: MAG-DHA
Placebo	Placebo comparator	Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 0 and 90 days

Secondary outcomes (10)

follow up of vital signs
weight (Kg)
Measured: 0 and 90 days
follow up of vital signs
Body Mass Index (BMI, Kg/cm2)
Measured: 0 and 90 days
follow up of vital signs
Blood Pressure (mmHg)
Measured: 0 and 90 days
lipid profile
triglycerides (mmol/l)
Measured: 0 and 90 days
lipid profile
cholesterol (mmol/l)
Measured: 0 and 90 days
lipid profile
high density lipoprotein (mmol/l)
Measured: 0 and 90 days
lipid profile
low density lipoprotein (mmol/l)
Measured: 0 and 90 days
hepatic function
measurement of Alanine aminotransferase (ALT) in plasma (U/l)
Measured: 0 and 90 days
hepatic function
measurement of Aspartate aminotransferase (AST) in plasma (U/l)
Measured: 0 and 90 days
hepatic function
measurement of Gamma glutamyl transpeptidase in plasma (U/l)
Measured: 0 and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Nov 2016

First posted10 Aug 2015 (estimated)
Study startOct 2015
Primary completionMar 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02518672
Sponsor's protocol ID: 14-108
Acronym: PREMDIC
Status last verified: Oct 2017
First submitted: 3 Aug 2015
Last updated: 4 Oct 2017
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 18036797
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.
PubMed 18441018
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.
PubMed 7697269
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.
PubMed 20638827
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.
PubMed 10570187
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.
PubMed 19828687
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.
PubMed 21057106
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.
PubMed 23092161
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.
PubMed 16325968
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.
PubMed 21297610
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.
PubMed 19247502
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.
PubMed 22863555
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.
PubMed 25781052

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis.
ClinicalTrials.gov ID: NCT02518672
Acronym / sponsor ID: PREMDIC / 14-108
Conditions: Cystic Fibrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 11 participants (actual)
Lead sponsor: SCF PharmaIndustry (pharma, biotech, devices)
Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Solutex GC S.L.
Study start: Oct 2015
Primary completion: Mar 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 10 Aug 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MAG-DHA	Active comparator	Dietary Supplement: MAG-DHAMAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

pregnant women or those not using contraception.
known allergy to fish and / or seafood.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MAG-DHAMAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.	Dietary supplement	MAG-DHA
PlaceboPlacebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.	Dietary supplement	Placebo

Primary outcome

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

10 secondary outcomes

follow up of vital signs
Time frame: 0 and 90 days
follow up of vital signs
Time frame: 0 and 90 days
follow up of vital signs
Time frame: 0 and 90 days
lipid profile
Time frame: 0 and 90 days
lipid profile
Time frame: 0 and 90 days
lipid profile
Time frame: 0 and 90 days
lipid profile
Time frame: 0 and 90 days
hepatic function
Time frame: 0 and 90 days
hepatic function
Time frame: 0 and 90 days
hepatic function
Time frame: 0 and 90 days

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
Background: PubMed 18036797Al-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.
Background: PubMed 18441018Andersson 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.
Background: PubMed 7697269Cantin 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.
Background: PubMed 20638827Dyerberg 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.
BackgroundFortin 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.
Background: PubMed 10570187Freedman 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.
Background: PubMed 19828687Mimoun 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.
Background: PubMed 21057106Morin 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.
Background: PubMed 23092161Morin 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.
Background: PubMed 16325968Panchaud 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.
Background: PubMed 21297610Pier G, Prince A, Cantin A. Cystic fibrosis: an-ion transport issue? Nat Med. 2011 Feb;17(2):166-7. doi: 10.1038/nm0211-166.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

André M Cantin, M.D. principal investigator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MAG-DHA in people with Cystic Fibrosis, run by SCF Pharma at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung and systemic inflammation measurement (time frame: 0 and 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02518672, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.