Influence of high dose vitamin D substitution onto the immune system in patients with type 1 diabetes mellitus or Addison´s disease (ViDDA1)

• Conditions: Type 1 diabetes mellitus or Addison´s disease (ViDDA1); MedDRA version: 14.1Level: HLGTClassification code 10001353Term: Adrenal gland disordersSystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-022677-34-DE
• Lead Sponsor: Dekan des Fachbereichs Humanmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Written informed consent before any study-related activities
•Ambulatory subject >18 and < 65 years of age
•Diabetes mellitus type 1, or
•Addison`disease,
•Women of child-bearing potential agreeing to a double-barrier method of contraception meeting a Pearl-Index below 1%

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known hypersensitivity to colecalciferol, or to any other excipient or to Miglyol Oil
•Active, consuming diseases (cancer, HIV)
•Renal failure (creatinine > 1,5mg/dl, GFR = 80)
•Malfunction of renal calcium and/or phosphate excretion
•Liver disease (AST, ALT > 1.5x ULN)
•Psychiatric diseases
•Hypercalcaemia (serum calcium > 2,6 mmol/l) or hypercalciuria (urine calcium to creatinine ratio > 1 mmol/l x (mmol/l) -1
•Nephrolyths (current or in patient’s history)
•Sarcoidosis (current or in patient’s history)
•Treatment with phenytoin, barbiturates, glycosides, benzothiazidine containing drugs, metabolites or analogues of bisphosphonates, calcium mimetics or vitamin D at present or in the last 6 weeks.
•Any significant disease, which, in the Investigator’s opinion, would have excluded the subject from the study
•Pregnancy or lactation
•Women of child-bearing potential not applying adequate contraceptive protection.
•Immobilised patients
•Pseudohypoparathyreodism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Difference in vitamin D levels, T lymphocyte subsets, T regulatory lymphocytes, dendritic cells and NK lymphocytes after 3 months of treatment between Vigantol Oil and Placebo Oil.;Secondary Objective: Difference in lymphocyte cytokine status (IL-1, IL-4, IL-10, TNFa), pharmacogenomics of vitamin D variables and vitamin D-dependent immune signatures after 3 months of treatment between Vigantol Oil and Placebo Oil.;Primary end point(s): The sample size calculation is based on the assumption that a variance of 4 and a difference of 0,5 for the quantification of the T lymphocyte subsets and dendritic cells and/or c) on the genes´ mRNA expression can be detected with a power of 80% and an alpha of 0.05.;Timepoint(s) of evaluation of this end point: After 3 months of study treatment in each arm

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none