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

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT01390480
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Cholecalciferol	peanut oil
Vitamin D (Oleovit®)	Cholecalciferol	cholecalciferol

Primary Outcome Measures

Name	Time	Method
Increase and function of regulatory T-cells	13 months	The level and function of the regulatory T-cells will be compared between the two groups.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Austria