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

NCT01055080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 987

Last updated 2010-01-25

No results posted yet for this study

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.

Conditions

  • Beta-cell Autoimmunity

Interventions

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

Sponsors & Collaborators

  • Valio Ltd

    collaborator INDUSTRY

  • University of Turku

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • University of Eastern Finland

    collaborator OTHER

  • Finnish Institute for Health and Welfare

    lead OTHER_GOV

Principal Investigators

  • Outi Vaarala, MD PhD · Finnish Institute for Health and Welfare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2006-06-30
Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01055080 on ClinicalTrials.gov