Skip to main content
OpenTrials
Completed

NCT Number: NCT01390480

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University Graz

Graz, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cholecalciferol

Drug

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

Other names: intervention: Oleovit D3, Placebo: peanut oil

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Calcium levels

    Time frame: 13 months

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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Medical University of Vienna

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 11, 2011
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.