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

Finnish Institute for Health and Welfare987 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

987

Conditions

Beta-cell Autoimmunity

Interventions

Cow's milk formulaDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * HLA-conferred genetic susceptibility for type 1 diabetes Exclusion Criteria: * Pre-term, maternal diabetes with insulin treatment

Outcomes

Primary Outcomes

Beta-cell autoantibodies

Time frame: 3,6,12,24,36,48,60,72 months

Data from ClinicalTrials.gov

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