EUCTR2010-022677-34-DEActive, not recruitingNot Applicable
Influence of high dose vitamin D substitution on humoral immunity and lymphocyte function in patients with type 1 diabetes mellitus or Addison´s disease (ViDDA1) - EMR200109-619
Dekan des Fachbereichs Humanmedizin0 sitesStarted: June 1, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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