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

January 22, 2010 updated by: Finnish Institute for Health and Welfare

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

987

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

  • Pre-term, maternal diabetes with insulin treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Cow's milk formula
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
ACTIVE_COMPARATOR: Bovine insulin-free whey based formula
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
ACTIVE_COMPARATOR: Whey-based hydrolysed formula
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beta-cell autoantibodies
Time Frame: 3,6,12,24,36,48,60,72 months
3,6,12,24,36,48,60,72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

University of Turku
University of Helsinki
University of Eastern Finland
Valio Ltd

Investigators

  • Principal Investigator: Outi Vaarala, MD PhD, Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (ESTIMATE)

January 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2010

Last Update Submitted That Met QC Criteria

January 22, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FINDIA2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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