Randomized controlled trial2017

Efficacy of docosahexaenoic acid-choline-vitamin E in paediatric NASH: a randomized controlled clinical trial

Zöhrer E, Alisi A, Jahnel J, Mosca A, Della Corte C, Crudele A, Fauler G, Nobili V

Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme · 58 citations

Review labels

Funding not disclosed

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Funding not disclosed

Publication

Published
2017-05-16 · Appl Physiol Nutr Metab · vol. 42 · issue 9 · pp. 948–954
Publisher
NRC Research Press
Cited
74 citations · more than 96% of similar papers · 4.9× the field average
Impact
Top 10% most cited in its field
References
46 works
Access
Open access (repository copy)
Research areas
Liver Disease Diagnosis and Treatment · Liver Disease and Transplantation · Pancreatitis Pathology and Treatment
Keywords
Nonalcoholic fatty liver disease, Internal medicine, Steatosis, Docosahexaenoic acid, Placebo, Medicine, Gastroenterology, FGF19, Liver biopsy, Randomized controlled trial, Nonalcoholic steatohepatitis, Choline, Fatty liver, Ursodeoxycholic acid, Endocrinology, Polyunsaturated fatty acid, Biopsy, Biochemistry, Fatty acid, Disease, Biology, Pathology, Fibroblast growth factor
MeSH
liver, humans, disease progression, choline, vitamin e, docosahexaenoic acids, biopsy, combined modality therapy, exercise, severity of illness index, follow-up studies, double-blind method, dietary supplements, adolescent, child, female, male, child nutritional physiological phenomena, non-alcoholic fatty liver disease, biomarkers, healthy lifestyle

8 authors

From AT, IT

  • Evelyn Zöhrer · correspondingMedical University of Graz
  • Anna Alisi · correspondingBambino Gesù Children's Hospital
  • Jörg JahnelMedical University of Graz
  • Antonella MoscaBambino Gesù Children's Hospital
  • Claudia Della CorteBambino Gesù Children's Hospital
  • Annalisa CrudeleBambino Gesù Children's Hospital

Abstract

Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease, is one of the most common hepatic diseases in children. We conducted a randomized controlled clinical trial on children with biopsy-proven NASH based on a combinatorial nutritional approach compared with placebo. Participants were assigned to lifestyle modification plus placebo or lifestyle modification plus a mix containing docosahexaenoic acid, choline, and vitamin E (DHA-CHO-VE). Forty children and adolescents participated in the entire trial. The primary outcome was the improvement of liver hyperechogenicity. Secondary outcomes included alterations of alanine aminotransferase (ALT) and other metabolic parameters. Furthermore, changes of serum bile acids (BA) and plasma fibroblast growth factor 19 (FGF19) levels were evaluated as inverse biomarkers of disease severity. At the end of the study, we observed a significant decrease in severe steatosis in the treatment group (50% to 5%, p = 0.001). Furthermore, although the anthropometric and biochemical measurements in the placebo and DHA-CHO-VE groups were comparable at baseline, at the end of the study ALT and fasting glucose levels improved only in the treatment group. Finally, we found that BA levels were not influenced whereas FGF19 levels were significantly increased by DHA-CHO-VE. The results suggest that a combination of DHA, VE, and CHO could improve steatosis and reduce ALT and glucose levels in children with NASH. However, further studies are needed to assess the impact of a DHA and VE combination on repair of liver damage in paediatric NASH.

Abstract via Europe PMC. Copyright remains with the authors or publisher.

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