Nutritional Prevention Pilot Trial for Type 1 Diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Dietary Supplement: A highly hydrolyzed formula; Dietary Supplement: A regular cow's milk based formula

• Registration Number: NCT00570102
• Lead Sponsor: University of Helsinki

Brief 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.

Study Timeline

• Study Start: 1995-02
• Primary Completion: 2004-03
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Study Completion: 2008-01
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• the participant must have a mother, biological father or sibling with type 1 diabetes
• the participant must carry a susceptible HLA genotype(HLA-DQB1*02 and/or DQB1*0302 without protective alleles (DQB1*0301, *0602 and *0603)

Exclusion Criteria

• no telephone
• no accessibility to any of the research centers
• inability of parents to understand the study and instructions
• unwillingness/inability to feed the infant CM-containing food for any reason (e.g. religious, cultural reasons)
• gestational age less than 36 weeks
• Any severe illness such as chromosomal abnormalities, congenital malformations, respiratory failure, enzyme deficiencies of the newborn.
• the newborn infant has received any cow's milk-based product prior to randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A highly hydrolyzed casein formula	A highly hydrolyzed formula	-
A conventiona cow's milk based formula	A regular cow's milk based formula	-

Primary Outcome Measures

Name	Time	Method
Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes	10 years

Trial Locations

Locations (18)

Jorvi Hospital; 🇫🇮 Espoo, Finland

University of Helsinki, Department of Obstetrics and Gynecology; 🇫🇮 Helsinki, Finland

National Public Health Institute; 🇫🇮 Helsinki, Finland

Kanta-Häme Central Hospital, Department of Pediatrics; 🇫🇮 Hämeenlinna, Finland

Helsinki University Hospital, Maternity Hospital; 🇫🇮 Helsinki, Finland

University of Helsinki, Hospital for Children and Adolescents; 🇫🇮 Helsinki, Finland

North Karelia Central Hospital; 🇫🇮 Joensuu, Finland

University of Oulu, Department of Pediatrics; 🇫🇮 Oulu, Finland

South Karelia Central Hospital; 🇫🇮 Lappeenranta, Finland

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Finland

Tampere University Hospital, Department of Pediatrics; 🇫🇮 Tampere, Finland

South Ostrobothnia Central Hospital; 🇫🇮 Seinäjoki, Finland

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland

Kymenlaakso Central Hospital, Department of Pediatrics; 🇫🇮 Kotka, Finland

University of Kuopio, Department of Pediatrics; 🇫🇮 Kuopio, Finland

Satakunta Central Hospital; 🇫🇮 Pori, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

University of Turku, Department of Virology; 🇫🇮 Turku, Finland