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

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ClinicalTrials.gov Identifier: NCT01826422
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : February 1, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Instituto Nacional de Rehabilitacion
Information provided by (Responsible Party):
Maricela Rodriguez Cruz, Coordinación de Investigación en Salud, Mexico

Brief 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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophy, Duchenne Dietary Supplement: EPA and DHA Dietary Supplement: Placebo Comparator Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Study Start Date : March 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: EPA and DHA
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.
Dietary Supplement: EPA and DHA
Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
Other Name: omega 3 fatty acid
Placebo Comparator: Placebo Comparator
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.
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%.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826422


Locations
Mexico
Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS.
Mexico city, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Instituto Nacional de Rehabilitacion
Investigators
Principal Investigator: Maricela Rodriguez-Cruz, PhD Instituto Mexicano del Seguro Social

Publications of Results:
Other Publications:
Responsible Party: Maricela Rodriguez Cruz, PhD, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01826422     History of Changes
Other Study ID Numbers: DHA/EPA in Dunchenne
180058 ( Other Grant/Funding Number: CONACYT )
First Posted: April 8, 2013    Key Record Dates
Results First Posted: February 1, 2018
Last Update Posted: March 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maricela Rodriguez Cruz, Coordinación de Investigación en Salud, Mexico:
Muscular Dystrophy
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Omega 3
Eicosapentaenoic fatty acid
Docosahexaenoic fatty acid

Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Inflammation
Muscular Dystrophies
Metabolic Diseases
Pathologic Processes
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked