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

Primary Purpose

Beta-cell Autoimmunity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cow's milk formula
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Beta-cell Autoimmunity focused on measuring type 1 diabetes, beta-cell autoantibodies, cow's milk formula, bovine insulin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

  • Pre-term, maternal diabetes with insulin treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Cow's milk formula

    Bovine insulin-free whey based formula

    Whey-based hydrolysed formula

    Arm Description

    Outcomes

    Primary Outcome Measures

    Beta-cell autoantibodies

    Secondary Outcome Measures

    Full Information

    First Posted
    January 22, 2010
    Last Updated
    January 22, 2010
    Sponsor
    Finnish Institute for Health and Welfare
    Collaborators
    Valio Ltd, University of Turku, University of Helsinki, University of Eastern Finland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01055080
    Brief Title
    Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study
    Acronym
    FINDIA
    Official Title
    Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Finnish Institute for Health and Welfare
    Collaborators
    Valio Ltd, University of Turku, University of Helsinki, University of Eastern Finland

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Beta-cell Autoimmunity
    Keywords
    type 1 diabetes, beta-cell autoantibodies, cow's milk formula, bovine insulin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    987 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cow's milk formula
    Arm Type
    Placebo Comparator
    Arm Title
    Bovine insulin-free whey based formula
    Arm Type
    Active Comparator
    Arm Title
    Whey-based hydrolysed formula
    Arm Type
    Active Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Cow's milk formula
    Intervention Description
    Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life
    Primary Outcome Measure Information:
    Title
    Beta-cell autoantibodies
    Time Frame
    3,6,12,24,36,48,60,72 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: HLA-conferred genetic susceptibility for type 1 diabetes Exclusion Criteria: Pre-term, maternal diabetes with insulin treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Outi Vaarala, MD PhD
    Organizational Affiliation
    Finnish Institute for Health and Welfare
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23274889
    Citation
    de Goffau MC, Luopajarvi K, Knip M, Ilonen J, Ruohtula T, Harkonen T, Orivuori L, Hakala S, Welling GW, Harmsen HJ, Vaarala O. Fecal microbiota composition differs between children with beta-cell autoimmunity and those without. Diabetes. 2013 Apr;62(4):1238-44. doi: 10.2337/db12-0526. Epub 2012 Dec 28.
    Results Reference
    derived
    PubMed Identifier
    22393174
    Citation
    Vaarala O, Ilonen J, Ruohtula T, Pesola J, Virtanen SM, Harkonen T, Koski M, Kallioinen H, Tossavainen O, Poussa T, Jarvenpaa AL, Komulainen J, Lounamaa R, Akerblom HK, Knip M. Removal of Bovine Insulin From Cow's Milk Formula and Early Initiation of Beta-Cell Autoimmunity in the FINDIA Pilot Study. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):608-14. doi: 10.1001/archpediatrics.2011.1559.
    Results Reference
    derived

    Learn more about this trial

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

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