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Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies

NCT02387164 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-11-17

Study results available
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Summary

The purpose of this study is to evaluate if immune-tolerance with Alum-formulated GAD (Diamyd), in combination with high dose Vitamin D3, may delay or stop the autoimmune process leading to clinical type 1 diabetes in non-diabetic children with ongoing beta-cell autoimmunity as indicated by positive islet autoantibodies.

Conditions

  • Diabetes Mellitus, Type 1
  • Prediabetic State

Interventions

DRUG

Alum-GAD

Two doses à 20 microgram 30 days apart subcutaneously administrated

DRUG

Vitamin D3

2000 Units (IE) (50 microgram) vitamin D3 daily

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER

  • Lund University

    lead OTHER

Principal Investigators

  • Helena Elding Larsson, MD, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-09
Primary Completion
2019-10-07
Completion
2019-10-07

Countries

  • Sweden

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 NCT02387164 on ClinicalTrials.gov