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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01055080
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : January 25, 2010
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment
Beta-cell Autoimmunity Dietary Supplement: Cow's milk formula

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 987 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2002
Primary Completion Date : June 2006
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Beta-cell autoantibodies [ Time Frame: 3,6,12,24,36,48,60,72 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: January 25, 2010
Last Verified: January 2010

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
Autoimmune Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs