NCT00570102

Nutritional Prevention Pilot Trial for Type 1 Diabetes

Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 1 Day – 7 Days
• Healthy volunteers: Accepted

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.

Detailed description

Among the environmental factors leading to type 1 diabetes in childhood, the most important are certain viral infections and possibly some dietary factors. Among the latter cow's milk proteins are of special interest. They have been shown to be involved in the pancreatic beta-cell lesion in animal experiments. In humans there are some indications of a role of early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. The hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention trial should provide a definite answer. This study aims at assessing whether one can decrease the future incidence of beta-cell autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the disease, by administering in infancy after breast feeding until the age of 6-8 months such a formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. The children in the control group, carrying a similar increased genetic risk, will receive a conventional cow's milk based formula . This project is a pilot multicenter trial comprising 15 hospitals in Finland.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	A highly hydrolyzed formula	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
DIETARY_SUPPLEMENT	A regular cow's milk based formula	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

Timeline

• Start date: 1995-02-01
• Primary completion: 2004-03-01
• Completion: 2008-01-01
• First posted: 2007-12-10
• Last updated: 2012-11-28

Locations

18 sites across 1 country: Finland