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

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01390480

ENM-DA-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 6 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

peanut oil

Treatment:

Drug: Cholecalciferol

Vitamin D (Oleovit®)

Active Comparator group

Description:

cholecalciferol

Treatment:

Drug: Cholecalciferol