NAFLD, Non Alcoholic Steatohepatitis (NASH)
Conditions
Keywords
NAFLD, NASH, DHA, VITAMIN D, OBESITY, CHILDREN
Brief summary
Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. The pathogenesis of NAFLD is generally considered the result of a series of liver injuries, commonly referred as multi-hit hypothesis. Several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression. The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (NAFLD).
Detailed description
Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical placebo (n=33) given orally for a period of 6 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise. Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months
Interventions
DRUGDHA plus Vitamin D
DHA 500 mg plus Vitamin D 800 IU
DRUGPlacebo
Placebo pearls mimicking pearls with DHA and Vitamin D
Sponsors
Bambino Gesù Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* biopsy consistent with the diagnosis of NAFLD/NASH * reduced serum levels of vitamin D aminotransferases (ALT) levels \<10 upper limit of normal * hyperechogenicity at liver ultrasound examination suggestive of fatty liver * International normalized ratio (INR) \< 1,3 * Albumin \> 3 g/dl * total bilirubin \< 2,5 mg/dl * no previous gastrointestinal bleeding * no previous portosystemic encephalopathy * normal renal function * no hepatitis B, hepatitis C infection * normal cell blood count
Exclusion criteria
* alcohol consumption * use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism * autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease * every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation * finding of active liver disease due to other causes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in NAFLD Activity Score (NAS) | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement of laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile | at 6 and 12 months | — |
| safety | 6 months | clinical examination, medical history and specific laboratory parameters |
Countries
Italy
Outcome results
None listed