Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children
This study is ongoing, but not recruiting participants.
Sponsor:
Piotr Socha
Collaborators:
Medical University of Bialystok
Medical University of Katowice, Poland
Pediatric Municipal Hospital of Rzeszow, Poland
Information provided by (Responsible Party):
Piotr Socha, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:
NCT01547910
First received: February 29, 2012
Last updated: March 8, 2012
Last verified: March 2012
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Purpose
The aim of this study is to evaluate efficacy of fish oil (EPA/DHA) in children with non-alcoholic fatty liver disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-alcoholic Fatty Liver Disease |
Dietary Supplement: Fish Oil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Supplementation of Fish Oil on Non-alcoholic Fatty Liver Disease in Children - a Randomized, Double Blind, Placebo Controlled, Multicenter Study |
Resource links provided by NLM:
Further study details as provided by Children's Memorial Health Institute, Poland:
Primary Outcome Measures:
- Serum alanine transaminase level decrease min. 0.3 upper limit of normal [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number of patients in whom ALT decreased min. 0.,3 ULN in 'fish oil' group compared to 'placebo' group
Secondary Outcome Measures:
- normalization of liver imaging on ultrasound [ Time Frame: after 6 months of therapy ] [ Designated as safety issue: Yes ]'Fish oil' group will be compared to 'placebo' group
- ALT and AST activity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]'Fish oil' group will be compared to 'placebo' group
- Insulin resistance markers as Homa-IR [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]'Fish oil' group will be compared to 'placebo' group
- Fat and lean body mass measurements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]'Fish oil' group will be compared to 'placebo' group
- Caloric intake including fat intake and sucrose intake [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]'Fish oil' group will be compared to 'placebo' group
| Enrollment: | 76 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fish oil
Children will receive fish oil capsules according to age as described in the protocol
|
Dietary Supplement: Fish Oil
Fish oil given in supplementary dose
|
|
Placebo Comparator: Placebo
Sunflower oil in the same capsules (the same shape and colour) given in the same regime as 'fish oil' capsules
|
Dietary Supplement: Fish Oil
Fish oil given in supplementary dose
|
Detailed Description:
76 children or adolescents aged 6-19 with NAFLD will be included in the study. Diagnosis of NAFLD is set by increased alanine transaminase and features of liver steatosis on ultrasound. Patients will be randomized to receive either fish oil (EPA/DHA, 400-1200mg) or placebo (sunflower oil) for 6 months. All children will be advised to reduce weight (dietetic intervention + increased physical activity). Laboratory tests, liver ultrasound, anthropometric analysis will be performed at the start, after 3 months and 6 months.
Eligibility| Ages Eligible for Study: | 6 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- age 6-19
- overweight or obesity
- ALT activity over 130% of upper limit norm
- hyperechogenicity of the liver on ultrasound
Exclusion Criteria:
- HCV, HBV infection
- cholestasis
- chronic/acute liver failure
- alpha-1-antitrypsin deficiency
- Wilson disease
- type 2 diabetes mellitus
- beta-oxidation defects
- alcohol consumption
- history of parenteral nutrition
- use of drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547910
Sponsors and Collaborators
Piotr Socha
Medical University of Bialystok
Medical University of Katowice, Poland
Pediatric Municipal Hospital of Rzeszow, Poland
Investigators
| Principal Investigator: | Piotr Socha | Children's Memorial Health Institute, Warsaw, Poland |
More Information
No publications provided
| Responsible Party: | Piotr Socha, Professor PhD MD, Principal Investigator, Children's Memorial Health Institute, Poland |
| ClinicalTrials.gov Identifier: | NCT01547910 History of Changes |
| Other Study ID Numbers: | ChildrensMHIPoland |
| Study First Received: | February 29, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Poland: Ministry of Science and Higher Education |
Keywords provided by Children's Memorial Health Institute, Poland:
|
fatty liver hepatitis insulin resistance unsaturated fatty acids NAFLD, children |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013