TREATMENT OF NONALCOHOLIC LIVER DISEASE IN CHILDREN (TONIC)

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。 这是一项多中心、隐蔽、安慰剂对照的随机临床试验，旨在确定与安慰剂治疗相比，二甲双胍或维生素E治疗96周是否导致患有NAFLD的非糖尿病儿童的血清ALT持续降低。在随机化之前可以有长达16周的筛查，96周的治疗阶段，然后24周的治疗后随访阶段。来自9个儿科站点的180名患者将被分成3组(每组60例：二甲双胍、维生素E、安慰剂)。

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. This is a multicenter, masked, placebo-controlled, randomized clinical trial designed to determine whether 96 weeks of treatment with either metformin or vitamin E leads to sustained reduction in serum ALT in nondiabetic children with NAFLD compared to treatment with placebo. There can be up to 16 weeks of screening prior to randomization, a 96-week treatment phase, and then a 24-week post-treatment follow-up phase. A total of 180 patients in 3 groups of equal size (60 per group: metformin, vitamin E, placebo) will be enrolled from 9 pediatric sites.