Abstract | BACKGROUND: METHODS/DESIGN: We are conducting a randomized, multicenter, double-blind, placebo-controlled trial of treatment with omega-3 fatty acids in children with NAFLD. Patients are randomized to receive either omega-3 fatty acids containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) or placebo for 24 weeks. The dose of omega-3 (DHA+ EPA) ranges from 450 to 1300 mg daily. Low calorie diet and increased physical activity are advised and monitored using validated questionnaires. The primary outcome of the trial is the number of patients who decreased ALT activity by ≥ 0,3 of upper limit of normal. The main secondary outcomes are improvement in the laboratory liver tests, liver steatosis on ultrasound, markers of insulin resistance and difference in fat/lean body mass composition after 6 months of intervention. DISCUSSION: TRIAL REGISTRATION: NCT01547910.
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Authors | Wojciech Janczyk, Piotr Socha, Dariusz Lebensztejn, Aldona Wierzbicka, Artur Mazur, Joanna Neuhoff-Murawska, Pawel Matusik |
Journal | BMC pediatrics
(BMC Pediatr)
Vol. 13
Pg. 85
(May 23 2013)
ISSN: 1471-2431 [Electronic] England |
PMID | 23702094
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Docosahexaenoic Acids
- Eicosapentaenoic Acid
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Topics |
- Adolescent
- Child
- Clinical Protocols
- Diet Records
- Dietary Supplements
- Docosahexaenoic Acids
(therapeutic use)
- Double-Blind Method
- Eicosapentaenoic Acid
(therapeutic use)
- Fatty Liver
(diet therapy)
- Follow-Up Studies
- Humans
- Non-alcoholic Fatty Liver Disease
- Research Design
- Treatment Outcome
- Young Adult
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