NCT01826422

Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: Male
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

DMD and DMB are X-linked diseases caused by mutations in the DMD gene, these mutations have important functional and structural consequences in skeletal muscle. In muscle fiber is observed inflammation and necrosis as a result of lost regenerative capacity. The muscle fibers can be replaced by connective and adipose tissue. In a previous study the investigators identified that 50% of Duchenne and Becker patients in the range of thirteen years old have obesity. In addition, these patients (N=66) have hyperinsulinemia (53.7%) and insulin resistance (48.5%). It is well known that obesity, hyperinsulinemia and insulin resistance have a inflammatory background. It has been demonstrated that eicosapentaenoic fatty acid (EPA) and docosahexaenoic fatty acid (DHA) exhibit anti-inflammatory properties and have beneficial effects on obesity, hyperinsulinemia and insulin resistance in children and adolescents. Objective: Determine the effect of EPA and DHA on inflammation, obesity and insulin resistance in patients with DMD/DMB compared to those receiving placebo.

Conditions

• Muscular Dystrophy, Duchenne

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	EPA and DHA	Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
DIETARY_SUPPLEMENT	Placebo Comparator	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%.

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-04-08
• Last updated: 2018-03-09
• Results posted: 2018-02-01

Locations

1 site across 1 country: Mexico