CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,156 enrolled
Drug / intervention
Hydrolysed infant formula +1 moredietary
Likely dose
Hydrolyzed casein infant formula (Nutramigen) or standard cow's milk formula with 20% Nutramigen, administered when breast milk unavailableAI-extracted
Key inclusion· 2
  • ✓Biological parent and/or full sibling of the newborn has type 1 diabetes (WHO-defined)
  • ✓Parent or legal guardian provides signed informed consent
Key exclusion· 9
  • ✕Older sibling already enrolled in TRIGR intervention
  • ✕Multiple gestation (twins, multiples)
  • ✕Family unwilling or unable to feed cow's milk-based products (religious, cultural, or other reasons)
  • ✕Severe congenital illness (chromosomal abnormality, congenital malformation, respiratory failure needing assisted ventilation, enzyme deficiencies, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00179777N/ACompleted
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TRIGR - Trial to Reduce IDDM in the Genetically at Risk

University of Helsinki·interventional·Posted Sep 16, 2005·Updated Jul 30, 2021

In Brief

A clinical study evaluating Hydrolysed infant formula and Nonhydrolysed infant formula for Diabetes Mellitus, Type 1. Completed, enrolled 5,156 participants across 18 sites in 15 countries.

Detailed 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 targeted at newborns who are at genetic risk for type 1 diabetes because their mother, father and/or full sibling has type 1 diabetes. All families were encouraged to breast feed their infants for as long as possible. Prior to birth, the child was randomly assigned to receive one of two infant formulas, should formula be required prior to 8 months of age. The study determined whether weaning to a possibly protective infant formula decreases these children's chances of developing diabetes - as it does in the animal models for diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesAustralia, Canada, Czechia, Estonia, Finland, Germany, Hungary, Italy, Luxembourg, Netherlands, Poland, Spain, Sweden, Switzerland, United States
CollaboratorsUnited States Congress, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Canadian Institutes of Health Research (CIHR), Juvenile Diabetes Research Foundation, European Community (EC), European Foundation for the Study of Diabetes, Mead Johnson Nutrition, Academy of Finland, Diabetes Research Foundation, Finland, Dutch Diabetes Research Foundation

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartMay 6, 2002
Primary CompletionMar 31, 2017
Study CompletionSep 30, 2017
TodayJul 2, 2026
Enrollment to primary: 14.9 yearsPosted 20.8 years ago

Interventions

Hydrolysed infant formuladietary

Participants in the Hydrolysed infant formula -group received the test formula, casein hydrolysate (Nutramigen™, Mead Johnson Nutritionals), not containing antigenic CM protein, whenever breast milk is not available.

Nonhydrolysed infant formuladietary

Participants in the Nonydrolysed infant formula -group received the CM protein containing control formula which has an addition (20 %) of Nutramigen, whenever breast milk is not available.