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

This study is ongoing, but not recruiting participants.
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: October 9, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated 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 IE/kg bodyweight/day) orally
Other Names:
  • intervention: Oleovit D3
  • Placebo: peanut oil
Active Comparator: Vitamin D (Oleovit®) Drug: Cholecalciferol
weekly dose (based on 70 IE/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
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: October 9, 2012
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 May 21, 2013