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

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ClinicalTrials.gov Identifier: NCT01055080
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : January 25, 2010
Sponsor:
Collaborators:
Valio Ltd
University of Turku
University of Helsinki
University of Eastern Finland
Information provided by:
Finnish Institute for Health and Welfare

Tracking Information
First Submitted Date  ICMJE January 22, 2010
First Posted Date  ICMJE January 25, 2010
Last Update Posted Date January 25, 2010
Study Start Date  ICMJE May 2002
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2010)
Beta-cell autoantibodies [ Time Frame: 3,6,12,24,36,48,60,72 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study
Official Title  ICMJE Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Beta-cell Autoimmunity
Intervention  ICMJE 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
Study Arms  ICMJE
  • Placebo Comparator: Cow's milk formula
    Intervention: Dietary Supplement: Cow's milk formula
  • Active Comparator: Bovine insulin-free whey based formula
    Intervention: Dietary Supplement: Cow's milk formula
  • Active Comparator: Whey-based hydrolysed formula
    Intervention: Dietary Supplement: Cow's milk formula
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2010)
987
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

  • Pre-term, maternal diabetes with insulin treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01055080
Other Study ID Numbers  ICMJE FINDIA2002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Outi Vaarala, National Institute for Health and Welfare, Finland
Study Sponsor  ICMJE Finnish Institute for Health and Welfare
Collaborators  ICMJE
  • Valio Ltd
  • University of Turku
  • University of Helsinki
  • University of Eastern Finland
Investigators  ICMJE
Principal Investigator: Outi Vaarala, MD PhD Finnish Institute for Health and Welfare
PRS Account Finnish Institute for Health and Welfare
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP