N/A
Completed N=40
Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients
Muscular Dystrophy, Duchenne
Source: ClinicalTrials.gov NCT01826422 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Body Composition (Body Fat) — 172.1; 232.7; 180.2; 274.8 g/Kg of body weight — p=<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.
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 |
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.
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. Informational only — not medical advice.