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

Coordinación de Investigación en Salud, Mexico

Status: Completed

Conditions: Muscular Dystrophy, Duchenne

Treatments: Dietary Supplement: Placebo Comparator; Dietary Supplement: EPA and DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT01826422

DHA/EPA in Dunchenne

180058 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

EPA and DHA

Experimental group

Description:

Supplementation of 2.7 g/d of EPA and DHA were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes were specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade.

Treatment:

Dietary Supplement: EPA and DHA

Placebo Comparator

Placebo Comparator group

Description:

Supplementation of placebo with sunflower fatty at doses of 2.7 g/d were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil, so, it did not present anti-inflammatory or insulin sensitivity effects.

Treatment:

Dietary Supplement: Placebo Comparator