VITAMIN E IN TREATMENT OF IGA NEPHROPATHY IN CHILDREN

维生素 E 治疗儿童 IGA 肾病

• 批准号: 6263689
• 负责人: JOSEPH T FLYNN
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263689
• 关键词: IgA nephropathy; blood chemistry; child (0-11); clinical research; clinical trials; human subject; longitudinal human study; nutrition related tag; tocopherols; urinalysis; vitamin therapy; young adult human (21-34)

At present, there is no treatment for IgA Nephropathy that has been proven to be clinically effective. This is a multicenter study in which children and young adults with biopsy-proven, clinically mild IgA Nephropathy will be randomized to receive either Vitamin E or placebo daily. After baseline laboratory data has been obtained and the subject has been randomized, they will be seen in follow-up every four months for a period of two years. Blood and urine samples will be obtained at these visits, and a 48 hour urine collection will be obtained annually. Risk of participation in the study is minimal, as there are no harmful effects of Vitamin E at the doses to be used in the study. The benefit to participation is possible amelioration of IgA Nephropathy in Vitamin E recipients if the treatment is effective; there is no direct benefit to placebo recipients. It is hoped that the results of this study will lead to an effective treatment for IgA Nephropathy.

目前，还没有临床上证明有效的伊加肾病治疗方法。 这是一项多中心研究，其中患有活检证实的临床轻度伊加肾病的儿童和年轻人将随机接受维生素E或安慰剂每日治疗。 在获得基线实验室数据并对受试者进行随机分组后，将每4个月进行一次随访，持续2年。将在这些访视时采集血液和尿液样本，每年采集48小时尿液。 参与研究的风险很小，因为研究中使用的剂量的维生素E没有有害影响。 如果治疗有效，参与的获益可能是维生素E接受者伊加肾病的改善;安慰剂接受者没有直接获益。 希望这项研究的结果将导致伊加肾病的有效治疗。