Trial record 10 of 121 for:    "Muscular Dystrophy, Duchenne"

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Instituto Nacional de Rehabilitacion
Information provided by (Responsible Party):
Maricela Rodriguez Cruz, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01826422
First received: April 4, 2013
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Muscular Dystrophy, Duchenne
Dietary Supplement: EPA and DHA
Dietary Supplement: Placebo Comparator: Sunflower oil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Eicosapentaenoic Fatty Acid(EPA)and Docosahexaenoic Fatty Acids(DHA) Supplementation in the Inflammation State and Metabolic Disorders in Patients With Duchenne Muscular Dystrophy or Becker Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Body composition [ Time Frame: Time Frame: At baseline, month 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: Yes ]
    Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA). We will measure changes in body composition: total body fat and lean mass.

  • Anthropometric Measurements [ Time Frame: Time Frame: At baseline, month 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: Yes ]
    We will perform and compare changes in anthropometric measurements. Parameters measured were: Weight, Height weight to calculate the body mass index.


Secondary Outcome Measures:
  • Inflammation biomarkers [ Time Frame: At baseline, at month 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: No ]

    Plasma cytokines interleukin (IL)-1, interleukin (IL)-6, tumoral necrosis factor (TNF)-alpha and C-reactive protein will be determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.

    The messenger ribonucleic acid (mRNA) expression of circulating cytokines IL-1, TNF and IL-6 will be determined by quantifying the real-time polymerase chain reaction (PCR).


  • Markers of muscle degeneration [ Time Frame: t baseline, at month 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
    The muscular degeneration will measure with percentage of DNA fragmentation per total DNA in plasma. The amount of molecules involving in the cascade apoptosis such as Bcl2 and Bax will be determined in serum by a sandwich enzyme linked immunosorbent assay (ELISA); and Fas ligand (FasL) and Bcl2 will be determined by relative expression of mRNA using real-time PCR.

  • Markers of muscle regeneration [ Time Frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
    Endothelial growth factors (VEGF) and fibroblast (FGF) will be quantified using enzyme linked immunosorbent assay (ELISA).

  • Incorporation of EPA and DHA in the erythrocytes [ Time Frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: No ]
    The percentage of total fatty acids in the membrane of erythrocytes will be determinated by gas chromatography.

  • Food frequency questionnaire [ Time Frame: At baseline, at month 1, 2, 3, 4, 5 and 6 ] [ Designated as safety issue: Yes ]
    The objective of the food frequency questionnaire is mainly to determine the intake of foods rich in DHA and EPA (p. example, fish oil). Also will be useful to know food intake with anti and pro-inflammatory.


Estimated Enrollment: 70
Study Start Date: March 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPA and DHA
Supplementation of 2.7 g / d of EPA and DHA will be 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 and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade.
Dietary Supplement: EPA and DHA
Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U.
Other Name: omega 3
Dietary Supplement: Placebo Comparator: Sunflower oil
The placebo capsules will also contain sunflower oil. Each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg.
Placebo Comparator: Sunflower oil
Supplementation of placebo with sunflower fatty at doses of 2.7 g / d will be 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 and so will not expected to produce anti-inflammatory or insulin sensitivity effects.
Dietary Supplement: EPA and DHA
Each capsule contains 245mg of DHA, 45mg of EPA, other omega 3 50mg, oleic acid 60mg and Vitamin E 7.5 I. U.
Other Name: omega 3
Dietary Supplement: Placebo Comparator: Sunflower oil
The placebo capsules will also contain sunflower oil. Each gram contains: myristic (C14: 0 0) 1 mg, palmitic (C16: 0) 62mg, stearic (C18: 0) 43mg, palmitoleic (C16: 1) 1mg, oleic (C18: 1) 202mg, linolenic (C18: 3) 1mg and linoleic (C18: 2) 632mg.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent and assent by the patient and both parent or guardian.
  • Patients with clinical diagnosis of Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (DMB)

Exclusion Criteria:

  • They decide to leave 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: April 4, 2013
Last Updated: April 5, 2013
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by 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
Metabolic Diseases
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Pathologic Processes

ClinicalTrials.gov processed this record on July 13, 2014