Type 1 diabetes mellitus or Addison´s disease (ViDDA1) MedDRA version: 14.1 Level: HLGT Classification code 10001353 Term: Adrenal gland disorders System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Vigantol Oil
Product Name: Colecalciferol
Pharmaceutical Form: Oral drops
INN or Proposed INN: Colecalciferol
CAS Number: 67 97 0
Other descriptive name: Vigantol
Concentration unit: mg/ml
Sponsors
Dekan des Fachbereichs Humanmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent before any study-related activities • Ambulatory subject >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Germany
Contacts
Public ContactUlrike Burkhardt
Consultant Clinical Research
Outcome results
None listed