N/A N=40 Randomized Quadruple-blind Prevention

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

Muscular Dystrophy, Duchenne

Bottom Line

View on ClinicalTrials.gov: NCT01826422 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: Body Composition (Body Fat) — 172.1; 232.7; 180.2; 274.8 g/Kg of body weight — p=<0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EPA and DHA (Dietary_supplement); Placebo Comparator (Dietary_supplement)
Age: Pediatric, Adult · 6+ yrs
Sex: Male
Sponsor: Coordinación de Investigación en Salud, Mexico
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Body Composition (Body Fat)	172.1; 232.7; 180.2; 274.8; 181.9; 298.2	<0.05 sig
PRIMARY Lean Mass	774.7; 662.4; 769.6; 647.7; 772.4; 630.6	>0.05
PRIMARY Anthropometric Measurement: Body Mass Index	42.5; 72.7; 48.2; 78.3; 49.6; 83.2	>0.05
PRIMARY Glucose in Serum	83.5; 89.0; 84.5; 90.0; 87.5; 89.0	<0.05 sig
PRIMARY Insulin in Blood	10.2; 20.9; 11.2; 17.8; 12.2; 18.5	<0.05 sig
SECONDARY Inflammation Biomarkers (TNF-A)	8.77; -1.45; -22.04; -21.01; -43.79; -37.76	>0.05
SECONDARY Inflammation Biomarkers (IL-1)	2.05; 21.74; -6.00; -2.49; -43.84; -9.89	<0.05 sig
SECONDARY Inflammation Biomarkers (IL-6)	0.60; 0.08; -10.57; -3.6; -29.33; -16.61	<0.05 sig
SECONDARY Inflammation Biomarkers (IL-10)	27.66; -8.89; 4.83; -21.16; 46.49; -39.91	<0.05 sig
SECONDARY Inflammation Biomarker (IL-6 Expression)	2.27; 2.45; 1.26; 5.33; 1.7; 7.82	<0.05 sig
SECONDARY Inflammation Biomarker (TNF-A Expression)	1.82; 1.15; 2.07; 1.05; 1.3; 2.12	<0.05 sig
SECONDARY Inflammation Biomarker (IL-1 Expression)	1.22; 1.7; 0.93; 1.08; 0.69; 0.86	0.05
SECONDARY Markers of Muscle Degeneration (Creatinine Kinase)	23.30; 8.82; 30.10; -9.95; 8.45; 0.75	>0.05
SECONDARY Markers of Muscle Degeneration (MMP9)	-31.5; -13.0; -3.5; 47.7; -21.2; 53.5	>0.05
SECONDARY Markers of Muscle Degeneration (sFas)	11.1; 15.8; 14.2; 15.8; 7.2; 14.5	>0.05
SECONDARY Markers of Muscle Degeneration (Receptor of Fas)	16.5; -2.0; 2.4; -10.1; -15.7; -16.3	>0.05
SECONDARY Markers of Muscle Regeneration (VEGF)	-25.9; -5.7; 2.4; -9.5; -15.7; -16.3	>0.05
SECONDARY Markers of Muscle Regeneration (FGF)	-13.6; -37.3; 2.4; -9.5; -0.92; -57.1	0.05
SECONDARY Incorporation of DHA in the Erythrocytes	57.8; 0.9; 31.1; -2.1; 153.4; -17.4	0.05
SECONDARY Incorporation of EPA in the Erythrocytes	233.0; -11.8; 300.4; -11.5; 552.6; -19.5	0.05

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT01826422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.