TREATMENT OF NON-ALCOHOLIC FATTY LIVER DISEASE IN CHILDREN

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 补药概述 儿童非酒精性脂肪性肝病的治疗(TONTIC)是由NIDDK和NICHD赞助的一项研究。这项研究的目的是确定与安慰剂相比，二甲双胍或维生素E治疗96周是否导致患有非酒精性脂肪性肝病的非糖尿病儿童的血清ALT持续降低。这是一项III期随机、多中心、隐蔽、安慰剂对照的临床试验。 有3个治疗组- 第1组：二甲双胍，500 mg，每日2次。和维生素E安慰剂，每天两次。 第2组：维生素E，400IU天然形式PO，每日2次。二甲双胍安慰剂b.i.d。 第3组：二甲双胍安慰剂，每日2次。和维生素E--安慰剂，每天两次。 人口- 8-17岁的非酒精性脂肪肝儿童首次筛查。 研究持续时间-每个患者 -随机化前最多16周(112天)的筛查，包括在随机化前使用抗非酒精性脂肪肝或抗糖尿病药物的至少3个月的药物洗脱 -96周治疗 -治疗后24周随访 学习持续时间-每个日历时间 -招聘阶段：2005年8月至2006年12月 -跟进阶段：2005年8月至2009年2月 临床中心数量--8个

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Summary of TONIC Treatment of Non-Alcoholic Fatty Liver Disease in Children (TONIC) is a study sponsored by NIDDK and NICHD. The objective of this study is to determine whether 96 weeks of treatment with either metformin or vitamin E leads to a sustained reduction in serum ALT in non-diabetic children with Non-Alcoholic Fatty Liver Disease compared to treatment with placebo. It is a phase III randomized, multicenter, masked, placebo controlled clinical trial. There are 3 treatment groups- Group 1 - Metformin, 500mg PO b.i.d. and vitamin E placebo b.i.d. Group 2 - Vitamin E, 400 IU natural form PO bi.d. and metformin placebo b.i.d. Group 3 - Metformin placebo b.i.d. and Vitamin E - placebo b.i.d. Population - Children with NAFLD aged 8-17 years at first screening visit. Study duration - per patient - Up to 16 weeks (112 days) of screening prior to randomization, including at least 3 months of drug washout for those using antiNAFLD or antidiabetic medications prior to randomization - 96 week treatment - 24 week post treatment follow up Study duration - per calendar time - Recruitment phase: August 2005 - December 2006 - Follow up phase: August 2005 - February 2009 Number of clinical centers - 8