Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes

April 16, 2015 updated by: Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • males or females > 6 years
  • new onset of type 1 diabetes (3 months)

Exclusion Criteria:

  • pregnancy
  • hypercalcemia (>2,65 mmol/L)
  • chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
peanut oil
Drug: Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Other Names:
  • intervention: Oleovit D3
  • Placebo: peanut oil
Active Comparator: Vitamin D (Oleovit®)
cholecalciferol
Drug: Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Other Names:
  • intervention: Oleovit D3
  • Placebo: peanut oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase and function of regulatory T-cells
Time Frame: 13 months
The level and function of the regulatory T-cells will be compared between the two groups.
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunophenotyping
Time Frame: 13 months
The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.
13 months
Insulin secretion
Time Frame: 13 months
Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.
13 months
Calcium levels
Time Frame: 13 months
Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 23, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENM-DA-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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