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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02518672 |
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Date of registration:
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03/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC)
PREMDIC |
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Scientific title:
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Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis. |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02518672 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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André M Cantin, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: MAG-DHA
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Primary Outcome(s)
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Lung and systemic inflammation measurement
[Time Frame: 0 and 90 days]
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Secondary Outcome(s)
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hepatic function
[Time Frame: 0 and 90 days]
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lipid profile
[Time Frame: 0 and 90 days]
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follow up of vital signs
[Time Frame: 0 and 90 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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