title: Study design of the Trial to Reduce IDDM in the Genetically at Risk (TRIGR).
abstract: The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes (T1D), as it does in all relevant animal models for the disease. This will be tested in children who carry risk-associated human leukocyte antigen genotypes and have a first-degree relative with T1D. The trial will use a double-blind, prospective, placebo-controlled intervention protocol, comparing casein hydrolysate with a conventional cow's milk (CM)-based formula. A secondary aim is to determine relationships between CM antibodies, a measure of CM exposure, and diabetes-associated autoantibodies. To achieve an 80% power for the detection of a 40% intervention-induced difference in the development of autoantibodies and subsequent diabetes, the study requires 2032 subjects. A multicenter, international, collaborative effort is necessary to achieve recruitment targets. A collaborative international study group of 78 clinical centers in 15 countries has therefore been assembled for this purpose.
authors.affiliation: Pediatrics Epidemiology Center, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL 33612, USA.
mesh_terms: D000818:Animals; D001323:Autoantibodies / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000453:epidemiology / Q000235:genetics* / Q000517:prevention & control*; D004311:Double-Blind Method; D006801:Humans; D015994:Incidence; D007223:Infant; D007225:Infant Food; D008892:Milk; D015337:Multicenter Studies as Topic; D010919:Placebos; D012107:Research Design; D018570:Risk Assessment
chemical_list: D001323:Autoantibodies; D010919:Placebos