Clinical trial NCT03472833: High-dose Vitamin D3 in Pancreas Cancer
Official title: Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreas Cancer
Vitamin D Deficiency
Quality of Life
Keywords: V
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3 therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a supportive standard therapy in pancreatic cancer patients.


Eligibility criteria: 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

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)
* metastasized pancreatic cancer
* normal vitamin D serum levels
* missing written informed consent

Primary outcomes:
measure: 25(OH) vitamin D
timeFrame: Day 60
Secondary outcomes:
measure: 25(OH) vitamin D
timeFrame: Day 30
measure: 1,25(OH)2D vitamin D
timeFrame: Day 30
measure: 1,25(OH)2D vitamin D
timeFrame: Day 60
measure: Urine Calcium
timeFrame: Day 30
measure: Urine Calcium
timeFrame: Day 60
measure: Osteocalcin
timeFrame: Day 30
measure: Osteocalcin
timeFrame: Day 60
measure: Beta-crosslaps
timeFrame: Day 30
measure: Beta-crosslaps
timeFrame: Day 60
measure: Calcium
timeFrame: Day 60
measure: Calcium
timeFrame: Day 30
measure: ionized calcium
timeFrame: Day 30
measure: ionized calcium
timeFrame: Day 60
measure: creatinine
timeFrame: Day 30
measure: creatinine
timeFrame: Day 60
measure: phosphate
timeFrame: Day 60
measure: phosphate
timeFrame: Day 30
measure: 60-day mortality
timeFrame: Day 60
measure: hospital stay
timeFrame: Day 60
measure: hospital readmission
timeFrame: Day 60
measure: hepcidin
timeFrame: Day 30
measure: hepcidin
timeFrame: Day 60
measure: Quality of Life questionnaire
timeFrame: Day 30
measure: Quality of Life questionnaire
timeFrame: Day 60
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz, Departement for General Surgery
name: Peter Kornprat, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: