CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 230 enrolled
Drug / intervention
A highly hydrolyzed formula +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00570102
NCT00570102Phase 2Completed
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Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study

University of Helsinki·interventional·Posted Dec 10, 2007·Updated Nov 28, 2012

In Brief

A Phase 2 clinical trial evaluating A highly hydrolyzed formula and A regular cow's milk based formula for Type 1 Diabetes Mellitus. Completed, enrolled 230 participants across 18 sites.

Detailed Summary

The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesFinland
CollaboratorsAcademy of Finland, European Union, Juvenile Diabetes Research Foundation, Diabetes Research Foundation, Finland, Novo Nordisk A/S

Timeline

Phase 2CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2007
Enrollment StartFeb 1, 1995
Primary CompletionMar 1, 2004
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 18.6 years ago

Interventions

A highly hydrolyzed formuladietary

Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months

A regular cow's milk based formuladietary

Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin