Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 in the Austrian Diabetes Prevention Programme
1 other identifier
interventional
31
1 country
1
Brief Summary
In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 23, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedApril 17, 2015
April 1, 2015
3 years
May 23, 2011
April 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase and function of regulatory T-cells
The level and function of the regulatory T-cells will be compared between the two groups.
13 months
Secondary Outcomes (3)
Immunophenotyping
13 months
Insulin secretion
13 months
Calcium levels
13 months
Study Arms (2)
Placebo
PLACEBO COMPARATORpeanut oil
Vitamin D (Oleovit®)
ACTIVE COMPARATORcholecalciferol
Interventions
weekly dose (based on 70 IU/kg bodyweight/day) orally
Eligibility Criteria
You may qualify if:
- males or females \> 6 years
- new onset of type 1 diabetes (3 months)
You may not qualify if:
- pregnancy
- hypercalcemia (\>2,65 mmol/L)
- chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Grazlead
- Medical University of Viennacollaborator
Study Sites (1)
Medical University Graz
Graz, Austria
Related Publications (1)
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.
PMID: 26277548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Pieber, Prof.
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2011
First Posted
July 11, 2011
Study Start
November 1, 2010
Primary Completion
November 1, 2013
Study Completion
February 1, 2014
Last Updated
April 17, 2015
Record last verified: 2015-04