High-dose vitamin D3 in pancreas cancer

Phase 1

• Conditions: vitamin D deficiency - pancreatic cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003489-28-AT
• Lead Sponsor: Medizinische Universität Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-13
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 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);Secondary Objective: 25(OH) vitamin D blood level on day 30<br>•1,25(OH)2D on day 30 and day 60<br>•urine calcium on day 30 and day 60<br>•60-day mortality<br>•hospital stay<br>•hospital readmission<br>•hepcidin blood level correlation to 25(OH)D<br>•EORTC QLQ-PAN 26 questionnaire<br>;Primary end point(s): Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL);Timepoint(s) of evaluation of this end point: day 60

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •25(OH) vitamin D blood level on day 30<br>•1,25(OH)2D on day 30 and day 60<br>•urine calcium on day 30 and day 60<br><br><br>•Osteocalcin on day 30 and day 60<br>•Beta-crosslaps on day 30 and day 60<br>•Calcium, ionized calcium, creatinine, phosphate on day 30 and day 60<br>•60-day mortality<br>•hospital stay<br>•hospital readmission<br>•hepcidin blood level on day 30 and day 60<br>•EORTC QLQ-PAN 26 questionnaire on day 30 and day 60<br>;Timepoint(s) of evaluation of this end point: day 30 and day 60