E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 diabetes mellitus or Addison´s disease (ViDDA1) |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes Mellitus or Addison´s disease |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10001353 |
E.1.2 | Term | Adrenal gland disorders |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtypes) |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Difference in lymphocyte cytokine status (IL-1, IL-4, IL-10, TNFα), pharmacogenomics of vitamin D variables and vitamin D-dependent immune signatures after 3 months of treatment between Vigantol Oil and Placebo Oil. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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%
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 3 months of study treatment in each arm |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunologic effect of study treatment |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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A recruitment period of 16 months is planned (Sep 11 until Dec 12). End of the trial is the last visit of last subject (LVLS) scheduled for June 2013. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |