NCT01826422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 1, 2018

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

3.8 years

First QC Date

April 4, 2013

Results QC Date

January 23, 2017

Last Update Submit

February 8, 2018

Conditions

Muscular Dystrophy, Duchenne

Keywords

Muscular DystrophyDuchenne Muscular DystrophyBecker Muscular DystrophyOmega 3Eicosapentaenoic fatty acidDocosahexaenoic fatty acid

Outcome Measures

Primary Outcomes (5)

  • Body Composition (Body Fat)

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

    At baseline and at months 3 and 6 of supplementation.

  • Lean Mass

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

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

  • Anthropometric Measurement: Body Mass Index

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

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

  • Glucose in Serum

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

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

  • Insulin in Blood

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

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

Secondary Outcomes (15)

  • Inflammation Biomarkers (TNF-A)

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

  • Inflammation Biomarkers (IL-1)

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

  • Inflammation Biomarkers (IL-6)

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

  • Inflammation Biomarkers (IL-10)

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

  • Inflammation Biomarker (IL-6 Expression)

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

  • +10 more secondary outcomes

Study Arms (2)

EPA and DHA

EXPERIMENTAL

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

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

Interventions

EPA and DHADIETARY_SUPPLEMENT

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

Also known as: omega 3 fatty acid
EPA and DHA
Placebo ComparatorDIETARY_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%.

Placebo Comparator

Eligibility Criteria

Age6 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, 06720, Mexico

Location

Related Publications (5)

  • Cruz Guzman Odel R, Chavez Garcia AL, Rodriguez-Cruz M. Muscular dystrophies at different ages: metabolic and endocrine alterations. Int J Endocrinol. 2012;2012:485376. doi: 10.1155/2012/485376. Epub 2012 Jun 3.

    PMID: 22701119BACKGROUND

  • Rodriguez-Cruz M, Sanchez R, Escobar RE, Cruz-Guzman Odel R, Lopez-Alarcon M, Bernabe Garcia M, Coral-Vazquez R, Matute G, Velazquez Wong AC. Evidence of Insulin Resistance and Other Metabolic Alterations in Boys with Duchenne or Becker Muscular Dystrophy. Int J Endocrinol. 2015;2015:867273. doi: 10.1155/2015/867273. Epub 2015 May 19.

    PMID: 26089900BACKGROUND

  • Rodriguez-Cruz M, Cruz-Guzman ODR, Almeida-Becerril T, Solis-Serna AD, Atilano-Miguel S, Sanchez-Gonzalez JR, Barbosa-Cortes L, Ruiz-Cruz ED, Huicochea JC, Cardenas-Conejo A, Escobar-Cedillo RE, Yam-Ontiveros CA, Ricardez-Marcial EF. Potential therapeutic impact of omega-3 long chain-polyunsaturated fatty acids on inflammation markers in Duchenne muscular dystrophy: A double-blind, controlled randomized trial. Clin Nutr. 2018 Dec;37(6 Pt A):1840-1851. doi: 10.1016/j.clnu.2017.09.011. Epub 2017 Sep 23.

    PMID: 28987470RESULT

  • Villaldama-Soriano MA, Rodriguez-Cruz M, Hernandez-De la Cruz SY, Almeida-Becerril T, Cardenas-Conejo A, Wong-Baeza C. Pro-inflammatory monocytes are increased in Duchenne muscular dystrophy and suppressed with omega-3 fatty acids: A double-blind, randomized, placebo-controlled pilot study. Eur J Neurol. 2022 Mar;29(3):855-864. doi: 10.1111/ene.15184. Epub 2021 Nov 26.

    PMID: 34779542DERIVED

  • Rodriguez-Cruz M, Atilano-Miguel S, Barbosa-Cortes L, Bernabe-Garcia M, Almeida-Becerril T, Cardenas-Conejo A, Del Rocio Cruz-Guzman O, Maldonado-Hernandez J. Evidence of muscle loss delay and improvement of hyperinsulinemia and insulin resistance in Duchenne muscular dystrophy supplemented with omega-3 fatty acids: A randomized study. Clin Nutr. 2019 Oct;38(5):2087-2097. doi: 10.1016/j.clnu.2018.10.017. Epub 2018 Oct 30.

    PMID: 30420291DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular Dystrophies

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Limitations and Caveats

Limitations: The sample size was not completed mainly because patients were not eligible for inclusion. It was not possible to standardize the technical procedures for DNA fragmentation evaluation.

Results Point of Contact

Title
Dr. Maricela Rodriguez-Cruz
Organization
IMSS
maricela.rodriguez.cruz@gmail.com
5256276900

Study Officials

  • Maricela Rodriguez-Cruz, PhD

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 8, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 9, 2018

Results First Posted

February 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)