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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Cholecalciferol

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring vitamin D, Autoimmune disease, diabetes

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Medical University Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin D (Oleovit®)

Arm Description

peanut oil

cholecalciferol

Outcomes

Primary Outcome Measures

Increase and function of regulatory T-cells

The level and function of the regulatory T-cells will be compared between the two groups.

Secondary Outcome Measures

Immunophenotyping

The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.

Insulin secretion

Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.

Calcium levels

Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.

Full Information

NCT ID

NCT01390480

First Posted

May 23, 2011

Last Updated

April 16, 2015

Sponsor

Medical University of Graz

Collaborators

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01390480

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Graz

Collaborators

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

vitamin D, Autoimmune disease, diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

peanut oil

Arm Title

Vitamin D (Oleovit®)

Arm Type

Active Comparator

Arm Description

cholecalciferol

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

intervention: Oleovit D3, Placebo: peanut oil

Intervention Description

weekly dose (based on 70 IU/kg bodyweight/day) orally

Primary Outcome Measure Information:

Title

Increase and function of regulatory T-cells

Description

The level and function of the regulatory T-cells will be compared between the two groups.

Time Frame

13 months

Secondary Outcome Measure Information:

Title

Immunophenotyping

Description

The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.

Time Frame

13 months

Title

Insulin secretion

Description

Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.

Time Frame

13 months

Title

Calcium levels

Description

Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.

Time Frame

13 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Pieber, Prof.

Organizational Affiliation

Medical University of Graz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University Graz

City

Graz

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

26277548

Citation

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.

Results Reference

derived

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

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