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Completed

NCT Number: NCT01826422

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

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.

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Key information

Conditions

Muscular Dystrophy, Duchenne Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

6 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS.

Mexico City, 06720, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EPA and DHA

Dietary Supplement

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

Other names: omega 3 fatty acid

Placebo Comparator

Dietary Supplement

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%.

Primary outcomes

  1. Body Composition (Body Fat)

    Time frame: At baseline and at months 3 and 6 of supplementation.

    We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).

  2. Lean Mass

    Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

    We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).

  3. Anthropometric Measurement: Body Mass Index

    Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

    We measured weight, height by anthropometric to calculate the body mass index (body mass index).

  4. Glucose in Serum

    Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

    A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.

  5. Insulin in Blood

    Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

    A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).

Secondary outcomes

  1. Inflammation Biomarkers (TNF-A)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  2. Inflammation Biomarkers (IL-1)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  3. Inflammation Biomarkers (IL-6)

    Time frame: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.

    Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  4. Inflammation Biomarkers (IL-10)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  5. Inflammation Biomarker (IL-6 Expression)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).

  6. Inflammation Biomarker (TNF-A Expression)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)

  7. Inflammation Biomarker (IL-1 Expression)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).

  8. Markers of Muscle Degeneration (Creatinine Kinase)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.

  9. Markers of Muscle Degeneration (MMP9)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 of supplementation.

    Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.

  10. Markers of Muscle Degeneration (sFas)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  11. Markers of Muscle Degeneration (Receptor of Fas)

    Time frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  12. Markers of Muscle Regeneration (VEGF)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).

  13. Markers of Muscle Regeneration (FGF)

    Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.

    Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

  14. Incorporation of DHA in the Erythrocytes

    Time frame: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

    The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.

  15. Incorporation of EPA in the Erythrocytes

    Time frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6

    The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Instituto Nacional de Rehabilitacion

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2013
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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