TREATMENT OF NON-ALCOHOLIC FATTY LIVER DISEASE IN CHILDREN

儿童非酒精性脂肪肝的治疗

• 批准号: 7951115
• 负责人: PARVATHI MOHAN
• 金额: $ 1.23万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951115
• 关键词: Aftercare; Antidiabetic Drugs; Calendar; Child; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Funding; Grant; Institution; Liver diseases; Masks; Metformin; National Institute of Child Health and Human Development; National Institute of Diabetes and Digestive and Kidney Diseases; Patients; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Population; Randomized; Research; Research Personnel; Resources; Screening procedure; Serum; Source; Time; United States National Institutes of Health; Visit; Vitamin E; aged; follow-up; non-alcoholic fatty liver; non-diabetic

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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 补品总结 儿童非酒精性脂肪肝治疗 (TONIC) 是一项由 NIDDK 和 NICHD 赞助的研究。本研究的目的是确定与安慰剂治疗相比，患有非酒精性脂肪肝病的非糖尿病儿童接受 96 周的二甲双胍或维生素 E 治疗是否会导致血清 ALT 持续降低。 这是一项 III 期随机、多中心、隐蔽、安慰剂对照临床试验。 有3个治疗组—— 第 1 组 - 二甲双胍，500mg PO b.i.d.和维生素 E 安慰剂每日两次 第 2 组 - 维生素 E，400 IU 天然形式，口服，每日两次和二甲双胍安慰剂每日两次 第 3 组 - 二甲双胍安慰剂 b.i.d.和维生素 E - 安慰剂 b.i.d. 人口 - 首次筛查就诊时患有 NAFLD 的儿童年龄为 8-17 岁。 研究持续时间 - 每个患者 - 随机分组前长达 16 周（112 天）的筛查，包括随机分组前使用抗 NAFLD 或抗糖尿病药物的患者至少 3 个月的药物清除期 - 96周治疗 - 治疗后24周随访 学习持续时间 - 每个日历时间 - 招募阶段：2005年8月-2006年12月 - 后续阶段：2005年8月-2009年2月 临床中心数量 - 8