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Nutritional Prevention Pilot Trial for Type 1 Diabetes

NCT00570102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2012-11-28

No results posted yet for this study

Summary

The overall objective of the study is to assess whether complete avoidance of cow's milk (CM) proteins, for at least the first 6 months of life, prevents type 1 diabetes (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a mother, biological father or sibling affected by type 1 diabetes.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DIETARY_SUPPLEMENT

A highly hydrolyzed formula

Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months

DIETARY_SUPPLEMENT

A regular cow's milk based formula

Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin

Sponsors & Collaborators

  • Academy of Finland

    collaborator OTHER

  • European Union

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Diabetes Research Foundation, Finland

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Hans K Åkerlom, MD, PhD · University of Helsinki, Helsinki, Finland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1995-02-28
Primary Completion
2004-03-31
Completion
2008-01-31

Countries

  • Finland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00570102 on ClinicalTrials.gov