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

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.

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Key information

Conditions

Beta-cell Autoimmunity Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HLA-conferred genetic susceptibility for type 1 diabetes

Exclusion criteria

Pre-term, maternal diabetes with insulin treatment

Treatment and study plan

Cow's milk formula

Dietary Supplement

Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life

Primary outcomes

Beta-cell autoantibodies

Time frame: 3,6,12,24,36,48,60,72 months

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

University of Eastern Finland
University of Helsinki
University of Turku
Valio Ltd

Registry information

Official study title

Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk

Acronym: FINDIA

Important dates

Study start: 2002
Primary completion: 2006
Study completion: 2009
First posted: Jan 25, 2010
Registry last updated: Jan 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed