Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in NAFLD Activity Score (NAS)
研究概览
简要总结
The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).
详细描述
Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 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 every three months during the 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months at the end of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistently elevated serum aminotransferase levels
- •diffusely echogenic liver on imaging studies suggestive of fatty liver
- •biopsy consistent with the diagnosis of NAFLD
排除标准
- •hepatic virus infections (HCV RNA-PCR negative)
- •Hepatitis A, B, C, D, E and G
- •cytomegalovirus and Epstein-Barr virus
- •alcohol consumption
- •history of parenteral nutrition
- •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 were ruled out using standard clinical, laboratory and histological criteria
研究组 & 干预措施
TREATED GROUP
DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg by mouth every day in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 6 months
干预措施: Docosahexaenoic Acid plus Vitamin E plus choline (Drug)
PLACEBO GROUP
placebo: this group will treated with identical placebo pearls given orally in association with lifestyle intervention [hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity] for 6 months
干预措施: placebo pearls (Drug)
结局指标
主要结局
Improvement in NAFLD Activity Score (NAS)
时间窗: 12 months
次要结局
- Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography(6 and 12 months)
研究者
Valerio Nobili
Head of Hepato-Metabolic Disease Unit, Bambino Gesù Children Hospital, IRCCS
Bambino Gesù Hospital and Research Institute