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

F

Finnish Institute for Health and Welfare

Status

Completed

Conditions

Beta-cell Autoimmunity

Treatments

Dietary Supplement: Cow's milk formula

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01055080
FINDIA2002

Details and patient eligibility

About

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.

Enrollment

987 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion criteria

  • Pre-term, maternal diabetes with insulin treatment

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

987 participants in 3 patient groups, including a placebo group

Cow's milk formula
Placebo Comparator group
Treatment:
Dietary Supplement: Cow's milk formula
Bovine insulin-free whey based formula
Active Comparator group
Treatment:
Dietary Supplement: Cow's milk formula
Whey-based hydrolysed formula
Active Comparator group
Treatment:
Dietary Supplement: Cow's milk formula

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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