Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study
FINDIA
Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
1 other identifier
interventional
987
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedJanuary 25, 2010
January 1, 2010
4.1 years
January 22, 2010
January 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Beta-cell autoantibodies
3,6,12,24,36,48,60,72 months
Study Arms (3)
Cow's milk formula
PLACEBO COMPARATORBovine insulin-free whey based formula
ACTIVE COMPARATORWhey-based hydrolysed formula
ACTIVE COMPARATORInterventions
Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life
Eligibility Criteria
You may qualify if:
- HLA-conferred genetic susceptibility for type 1 diabetes
You may not qualify if:
- Pre-term, maternal diabetes with insulin treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finnish Institute for Health and Welfarelead
- Valio Ltdcollaborator
- University of Turkucollaborator
- University of Helsinkicollaborator
- University of Eastern Finlandcollaborator
Related Publications (2)
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.
PMID: 23274889DERIVEDVaarala 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.
PMID: 22393174DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Outi Vaarala, MD PhD
Finnish Institute for Health and Welfare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
May 1, 2002
Primary Completion
June 1, 2006
Study Completion
December 1, 2009
Last Updated
January 25, 2010
Record last verified: 2010-01