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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
  Purpose

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.


Condition Intervention
Beta-cell Autoimmunity
 Dietary Supplement: Cow's milk formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Beta-cell autoantibodies [ Time Frame: 3,6,12,24,36,48,60,72 months ] [ Designated as safety issue: No ]

Enrollment: 987
Study Start Date: May 2002
Study Completion Date: December 2009
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion Criteria:

  • Pre-term, maternal diabetes with insulin treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055080

Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Valio Ltd
University of Turku
Helsinki University
University of Eastern Finland
Investigators
Principal Investigator: Outi Vaarala, MD PhD National Institute for Health and Welfare, Finland
  More Information

No publications provided by National Institute for Health and Welfare, Finland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Outi Vaarala, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01055080     History of Changes
Other Study ID Numbers: FINDIA2002
Study First Received: January 22, 2010
Last Updated: January 22, 2010
Health Authority: Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
type 1 diabetes
beta-cell autoantibodies
cow's milk formula
bovine insulin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013