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

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ClinicalTrials.gov Identifier: NCT01390480
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Cholecalciferol Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2010
Primary Completion Date : November 2013
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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®)
cholecalciferol
Drug: Cholecalciferol
weekly dose (based on 70 IU/kg bodyweight/day) orally
Other Names:
  • intervention: Oleovit D3
  • Placebo: peanut oil


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01390480     History of Changes
Other Study ID Numbers: ENM-DA-017
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

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
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents