Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk

Finnish Institute for Health and Welfare0 个研究点目标入组 987 人开始时间: 2002年5月1日最近更新: 2010年1月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 987
主要终点: Beta-cell autoantibodies

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别: All
接受健康志愿者: 是

入选标准

•HLA-conferred genetic susceptibility for type 1 diabetes

排除标准

•Pre-term, maternal diabetes with insulin treatment

结局指标

主要结局

Beta-cell autoantibodies

时间窗: 3,6,12,24,36,48,60,72 months

次要结局

未报告次要终点

研究者

发起方

Finnish Institute for Health and Welfare

申办方类型

Other Gov

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