drugset / Trial / NCT00885313
Effects of Docosahexaenoic Acid (DHA) on Children With Nonalcoholic Fatty Liver Disease (NAFLD)
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
Timeline
- Start
- 2009-03
- Primary completion
- 2010-04
- Completion
- 2011-03
Outcome
Met primary endpoint
paper DHA supplementation improves liver steatosis in children with NAFLD. PMID 23220074 ↗
paper DHA 250 mg/day (OR = 0.01, 0.002 to 0.11, p <0.001) PMID 21233083 ↗
paper DHA 500 mg/day (OR = 0.04, 0.002 to 0.46, p = 0.01) PMID 21233083 ↗
Publications
- Nobili V, Bedogni G, Donati B, Alisi A, Valenti L. The I148M variant of PNPLA3 reduces the response to docosahexaenoic acid in children with non-alcoholic fatty liver disease. J Med Food. 2013 Oct;16(10):957-60. doi: 10.1089/jmf.2013.0043. Epub 2013 Sep 28.
- Nobili V, Alisi A, Della Corte C, Rise P, Galli C, Agostoni C, Bedogni G. Docosahexaenoic acid for the treatment of fatty liver: randomised controlled trial in children. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1066-70. doi: 10.1016/j.numecd.2012.10.010. Epub 2012 Dec 7.
- Nobili V, Bedogni G, Alisi A, Pietrobattista A, Rise P, Galli C, Agostoni C. Docosahexaenoic acid supplementation decreases liver fat content in children with non-alcoholic fatty liver disease: double-blind randomised controlled clinical trial. Arch Dis Child. 2011 Apr;96(4):350-3. doi: 10.1136/adc.2010.192401. Epub 2011 Jan 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DOCONEXENT | Other / unclassified | 250 mg/kg | Oral |
| Subject | DOCONEXENT | Other / unclassified | 500 mg/kg | Oral |