Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study

Not Applicable

Completed

• Conditions: Beta-cell Autoimmunity
• Interventions: Dietary Supplement: Cow's milk formula

• Registration Number: NCT01055080
• Lead Sponsor: Finnish Institute for Health and Welfare

Brief Summary

The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2006-06
• Study Completion: 2009-12
• Status Verified: 2010-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Last Update Submitted: 2010-01-22
• Study First Posted: 2010-01-25
• Last Update Posted: 2010-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 987

Inclusion Criteria

• HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria

• Pre-term, maternal diabetes with insulin treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cow's milk formula	Cow's milk formula	-
Whey-based hydrolysed formula	Cow's milk formula	-
Bovine insulin-free whey based formula	Cow's milk formula	-

Primary Outcome Measures

Name	Time	Method
Beta-cell autoantibodies	3,6,12,24,36,48,60,72 months