CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
EPA and DHA +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01826422
NCT01826422N/ACompleted
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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

Coordinación de Investigación en Salud, Mexico·interventional·Posted Apr 8, 2013·Updated Mar 9, 2018

In Brief

A clinical study evaluating EPA and DHA and Placebo Comparator for Muscular Dystrophy, Duchenne. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well as the process of muscular regeneration and the metabolic disorders like obesity and insulin resistance in patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (DMB) compared to those receiving placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMuscular Dystrophy, Duchenne
CountriesMexico
CollaboratorsInstituto Nacional de Rehabilitacion

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2013
Enrollment StartMar 1, 2013
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.2 years ago

Interventions

EPA and DHAdietary

Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.

Placebo Comparatordietary

Placebo capsules will contain gelatin and sunflower oil. Fatty acid composition is as follows: lauric (C12:0), 0.19%; myristic (C14:0), 0.29%; palmitic (C16:0), 7.59%; palmitoleic (C16:1), 0.25%; stearic (C18:0), 3.49%; oleic (C18:1), 31.08%; linolenic (C18:3), 1.13%; linoleic (C18:2), 55.64%; DHA 0.02%; arachidic (C20:0), 0.30% and arachidonic (C20:4), 0.01%.