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Early Dietary Intervention and Later Signs of Beta-Cell Autoimmunity

NCT01735123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2017-02-27

No results posted yet for this study

Summary

The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by which an extensively hydrolyzed casein formula is able to protect children at risk for type 1 diabetes (T1D) from beta-cell autoimmunity.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DIETARY_SUPPLEMENT

dietary intervention

hydrolyzed vs. nonhydrolyzed infant formula

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER

  • Finnish Institute for Health and Welfare

    collaborator OTHER_GOV

  • Tampere University Hospital

    collaborator OTHER

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Mikael Knip, M.D. · University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-07-31
Completion
2016-08-31

Countries

  • Finland

Study Locations

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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 NCT01735123 on ClinicalTrials.gov