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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Patients will receive a high dose - 180.000 I.U. (1 drop equals 400 I.U.) of Vitamin D3 orally on day 1, and then 4000 I.U. for 60 days
Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days
Medical University of Graz
Graz, Styria, Austria
25(OH) vitamin D
Blood level of Vitamin D3
Time frame: Day 60
25(OH) vitamin D
Blood level of Vitamin D3
Time frame: Day 30
1,25(OH)2D vitamin D
Blood level of 1,25(OH)2D vitamin D
Time frame: Day 30
1,25(OH)2D vitamin D
Blood level of 1,25(OH)2D vitamin D
Time frame: Day 60
Urine Calcium
Calcium level in urine
Time frame: Day 30
Urine Calcium
Calcium level in urine
Time frame: Day 60
Osteocalcin
Bone marker measured in blood
Time frame: Day 30
Osteocalcin
Bone marker measured in blood
Time frame: Day 60
Beta-crosslaps
Bone marker measured in blood
Time frame: Day 30
Beta-crosslaps
Bone marker measured in blood
Time frame: Day 60
Calcium
blood measurement
Time frame: Day 60
Calcium
blood measurement
Time frame: Day 30
ionized calcium
blood measurement
Time frame: Day 30
ionized calcium
blood measurement
Time frame: Day 60
creatinine
blood measurement
Time frame: Day 30
creatinine
blood measurement
Time frame: Day 60
phosphate
blood measurement
Time frame: Day 60
phosphate
blood measurement
Time frame: Day 30
60-day mortality
Number of patients who die in the specified timeframe
Time frame: Day 60
hospital stay
Hospital stay in days
Time frame: Day 60
hospital readmission
Number of readmissions
Time frame: Day 60
hepcidin
blood level marker for iron status
Time frame: Day 30
hepcidin
blood level marker for iron status
Time frame: Day 60
Quality of Life questionnaire
evaluated by EORTC questionnaire
Time frame: Day 30
Quality of Life questionnaire
evaluated by EORTC questionnaire
Time frame: Day 60
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