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

Beta-cell Autoimmunity Clinical Trial

— FINDIA  

Official title:

Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055080
• Other study ID #: FINDIA2002
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: January 22, 2010
• Start date: May 2002
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 987
• Est. completion date: December 2009
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

• Pre-term, maternal diabetes with insulin treatment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Autoimmune Diseases
• Beta-cell Autoimmunity
• Diabetes Mellitus, Type 1

Intervention

Dietary Supplement:
• Cow's milk formula
Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Helsinki University, University of Eastern Finland, University of Turku, Valio Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-cell autoantibodies		3,6,12,24,36,48,60,72 months	No