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

This study has been completed.
Sponsor:
Collaborators:
Valio Ltd
University of Turku
Helsinki University
University of Eastern Finland
Information provided by:
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01055080
First received: January 22, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 22, 2010
January 22, 2010
May 2002
June 2006   (final data collection date for primary outcome measure)
Beta-cell autoantibodies [ Time Frame: 3,6,12,24,36,48,60,72 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Beta-cell Autoimmunity
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
  • 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
de Goffau MC, Luopajärvi K, Knip M, Ilonen J, Ruohtula T, Härkönen T, Orivuori L, Hakala S, Welling GW, Harmsen HJ, Vaarala O. Fecal microbiota composition differs between children with β-cell autoimmunity and those without. Diabetes. 2013 Apr;62(4):1238-44. doi: 10.2337/db12-0526. Epub 2012 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
987
December 2009
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

  • Pre-term, maternal diabetes with insulin treatment
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01055080
FINDIA2002
No
Outi Vaarala, National Institute for Health and Welfare, Finland
National Institute for Health and Welfare, Finland
  • Valio Ltd
  • University of Turku
  • Helsinki University
  • University of Eastern Finland
Principal Investigator: Outi Vaarala, MD PhD National Institute for Health and Welfare, Finland
National Institute for Health and Welfare, Finland
January 2010

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