Efficacy and Tolerability of Vitamin D and Docosahexaenoic Acid (DHA) in Children With Biopsy Proven NAFLD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Improvement in NAFLD Activity Score (NAS)
研究概览
简要总结
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).
详细描述
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
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
- •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
排除标准
- •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
研究组 & 干预措施
TREATED GROUP
this group will treated with pearls containing DHA plus Vitamin D3 (500 mg and 800 IU, respectively) 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 24 weeks
干预措施: DHA plus Vitamin D (Drug)
PLACEBO GROUP
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 24 weeks
干预措施: Placebo (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 laboratory parameters of metabolic syndrome, such as lipids and gluco-insulinemic profile(at 6 and 12 months)
- safety(6 months)
研究者
Valerio Nobili
Professor
Bambino Gesù Hospital and Research Institute