E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
vitamin D deficiency - pancreatic cancer |
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E.1.1.1 | Medical condition in easily understood language |
vitamin D deficiency - pancreatic cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
Evaluate that a high dose vitamin D supplementation leads to a higher 25(OH) vitamin D blood level versus the standard supplementation in pancreatic cancer patients-Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL) |
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E.2.2 | Secondary objectives of the trial |
25(OH) vitamin D blood level on day 30
• 1,25(OH)2D on day 30 and day 60
• urine calcium on day 30 and day 60
• 60-day mortality
• hospital stay
• hospital readmission
• hepcidin blood level correlation to 25(OH)D
• EORTC QLQ-PAN 26 questionnaire
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• both sexes
• vitamin D deficiency (< 20ng/ml)
• patients > 18 years of age
• pancreatic Cancer
• surgical intervention/non-surgical Intervention
• signed written informed consent
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E.4 | Principal exclusion criteria |
• patients < 18 years of age
• pregnancy
• contraindication for oral vitamin D intake
• hypercalcemia (> 2.65 mmol/l total calcium and/or > 1.35 mmol/l ionized calcium at screening)
• other ongoing vitamin D conducted trial
• known kidney stones, active tuberculosis or sarcoidosis (in the last 12 months)
• normal vitamin D serum levels
metastasized pancreatic Cancer
missing written informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• 25(OH) vitamin D blood level on day 30
• 1,25(OH)2D on day 30 and day 60
• urine calcium on day 30 and day 60
• Osteocalcin on day 30 and day 60
• Beta-crosslaps on day 30 and day 60
• Calcium, ionized calcium, creatinine, phosphate on day 30 and day 60
• 60-day mortality
• hospital stay
• hospital readmission
• hepcidin blood level on day 30 and day 60
• EORTC QLQ-PAN 26 questionnaire on day 30 and day 60
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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 | No |
E.6.4 | Safety | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard dose cholecalciferol |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 26 |
E.8.9.1 | In the Member State concerned days | |