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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01390480

Enrollment

Registered

2011-07-11

Start date

2010-11-30

Completion date

2014-02-28

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

vitamin D, Autoimmune disease, diabetes

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.

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.

Interventions

DRUGCholecalciferol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Increase and function of regulatory T-cells	13 months	The level and function of the regulatory T-cells will be compared between the two groups.

Secondary

Measure	Time frame	Description
Immunophenotyping	13 months	The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.
Insulin secretion	13 months	Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.
Calcium levels	13 months	Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026