Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
NCT ID: NCT01390480
Last Updated: 2015-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2010-11-30
2014-02-28
Brief Summary
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Detailed Description
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The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
peanut oil
Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Vitamin D (Oleovit®)
cholecalciferol
Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Interventions
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Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* new onset of type 1 diabetes (3 months)
Exclusion Criteria
* hypercalcemia (\>2,65 mmol/L)
* chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
6 Years
60 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Thomas Pieber, Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Medical University Graz
Graz, , Austria
Countries
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References
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Treiber G, Prietl B, Frohlich-Reiterer E, Lechner E, Ribitsch A, Fritsch M, Rami-Merhar B, Steigleder-Schweiger C, Graninger W, Borkenstein M, Pieber TR. Cholecalciferol supplementation improves suppressive capacity of regulatory T-cells in young patients with new-onset type 1 diabetes mellitus - A randomized clinical trial. Clin Immunol. 2015 Dec;161(2):217-24. doi: 10.1016/j.clim.2015.08.002. Epub 2015 Aug 12.
Other Identifiers
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ENM-DA-017
Identifier Type: -
Identifier Source: org_study_id
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