A Phase 2 interventional study of A highly hydrolyzed formula and A regular cow's milk based formula in Type 1 Diabetes Mellitus, sponsored by University of Helsinki. Completed at 18 sites in Finland. Open to participants aged 1 Day to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-28.
Sponsored by University of Helsinki · Phase 2, Interventional, and Prevention
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 230 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: A highly hydrolyzed formula
Dietary Supplement: A regular cow's milk based 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
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
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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University of Helsinki