Status:
COMPLETED
TRIGR - Primary Prevention Study for Type 1 Diabetes in Children at Risk
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
United States Congress
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief Summary
The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) is an international effort to conduct a primary prevention nutrition trial for type 1 (insulin-dependent) diabetes. The TRIGR study was targ...
Detailed Description
The hypothesis for this study is that weaning to an extensively hydrolyzed infant formula will decrease the incidence of type 1 diabetes in subjects with risk-associated HLA genotypes and a first degr...
Eligibility Criteria
Inclusion
- Biological parent and/or full (not half) sibling of the newborn infant had type 1 diabetes as defined by the World Health Organization
- The infant's parent or legal guardians gave signed consent to participate
Exclusion
- An older sibling of the newborn infant had been included in the TRIGR intervention
- Multiple gestation
- The parents were unwilling or unable to feed the infant cow's milk based products for any reason (e.g., religious, cultural).
- The newborn infant had a recognizable severe illness such as those due to chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.
- The gestational age of the newborn infant was less than 35 weeks.
- The infant was older than 7 days at randomization.
- Inability of the family to take part in the study (e.g. the family has no access to any of the Study Centers, the family has no telephone).
- The infant had received any infant formula other than Nutramigen prior to randomization.
- No HLA sample drawn before the age of 8 days.
Key Trial Info
Start Date :
May 6 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2017
Estimated Enrollment :
5156 Patients enrolled
Trial Details
Trial ID
NCT00179777
Start Date
May 6 2002
End Date
September 30 2017
Last Update
July 30 2021
Active Locations (18)
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1
The University of South Florida
Tampa, Florida, United States, 33620
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213-2583
3
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
4
Robarts Research Institute
London, Ontario, Canada, N6A 5K8