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

This study has been completed.
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01390480
First received: May 23, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Drug: Cholecalciferol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Increase and function of regulatory T-cells [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The level and function of the regulatory T-cells will be compared between the two groups.


Secondary Outcome Measures:
  • Immunophenotyping [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.

  • Insulin secretion [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.

  • Calcium levels [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
    Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.


Enrollment: 31
Study Start Date: November 2010
Study Completion Date: February 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®) Drug: Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Other Names:
  • intervention: Oleovit D3
  • Placebo: peanut oil

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.

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390480

Locations
Austria
Medical University Graz
Graz, Austria
Sponsors and Collaborators
Medical University of Graz
Medical University of Vienna
Investigators
Principal Investigator: Thomas Pieber, Prof. Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01390480     History of Changes
Other Study ID Numbers: ENM-DA-017
Study First Received: May 23, 2011
Last Updated: April 3, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
vitamin D
Autoimmune disease
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 28, 2014