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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390480
• Other study ID #: ENM-DA-017
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2011
• Last updated: April 16, 2015
• Start date: November 2010
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Immunophenotyping	The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.	13 months	No
Secondary	Insulin secretion	Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.	13 months	No
Secondary	Calcium levels	Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.	13 months	Yes