Nutritional Prevention Pilot Trial for Type 1 Diabetes (MIP)
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|ClinicalTrials.gov Identifier: NCT00570102|
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Dietary Supplement: A highly hydrolyzed formula Dietary Supplement: A regular cow's milk based formula||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study|
|Study Start Date :||February 1995|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||January 2008|
|Active Comparator: A highly hydrolyzed casein formula||
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
|Placebo Comparator: A conventiona cow's milk based formula||
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
- Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570102
|Principal Investigator:||Hans K Åkerlom, MD, PhD||University of Helsinki, Helsinki, Finland|