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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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12 December 2020 |
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Main ID: |
NCT01826422 |
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Date of registration:
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04/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients
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Scientific title:
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Effect of Eicosapentaenoic Fatty Acid (EPA) and Docosahexaenoic Fatty Acids (DHA) Supplementation on the Inflammation State and Metabolic Disorders in Patients With Duchenne Muscular Dystrophy or Becker Muscular Dystrophy |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01826422 |
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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: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Maricela Rodriguez-Cruz, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Mexicano del Seguro Social |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent and assent by the patient and both parents or guardian.
- Patients with clinical diagnosis of Duchenne Muscular Dystrophy (DMD) or Becker
Muscular Dystrophy (DMB)
- Patients were not under treatment with corticosteroids
Exclusion Criteria:
- Patients decided to withdraw from the study
- Consumption of dietary supplements containing polyunsaturated fatty acids omega 3.
- With hypersensitivity to fish oil.
- Patients with respiratory and gastrointestinal problems. Medical responsible
assessment the presence of respiratory and gastrointestinal problems.
- Patients with difficulty swallowing food, including those who have the difficulty
ingesting oil capsules.
- Gastrostomy fed patients.
Age minimum:
6 Years
Age maximum:
18 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Muscular Dystrophy, Duchenne
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Intervention(s)
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Dietary Supplement: EPA and DHA
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Dietary Supplement: Placebo Comparator
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Primary Outcome(s)
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Glucose in Serum
[Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.]
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Lean Mass
[Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.]
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Anthropometric Measurement: Body Mass Index
[Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.]
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Insulin in Blood
[Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.]
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Body Composition (Body Fat)
[Time Frame: At baseline and at months 3 and 6 of supplementation.]
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Secondary Outcome(s)
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Inflammation Biomarker (TNF-A Expression)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Markers of Muscle Degeneration (Creatinine Kinase)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Inflammation Biomarkers (IL-1)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Markers of Muscle Degeneration (sFas)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Markers of Muscle Regeneration (VEGF)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Incorporation of DHA in the Erythrocytes
[Time Frame: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.]
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Inflammation Biomarker (IL-1 Expression)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Inflammation Biomarkers (TNF-A)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Markers of Muscle Regeneration (FGF)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Markers of Muscle Degeneration (MMP9)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 of supplementation.]
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Incorporation of EPA in the Erythrocytes
[Time Frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6]
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Inflammation Biomarkers (IL-6)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.]
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Inflammation Biomarker (IL-6 Expression)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Inflammation Biomarkers (IL-10)
[Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Markers of Muscle Degeneration (Receptor of Fas)
[Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.]
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Secondary ID(s)
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180058
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DHA/EPA in Dunchenne
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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