Pancreas Cancer, Vitamin D Deficiency, Quality of Life
Conditions
Keywords
V
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.
Interventions
DRUGHigh-dose
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
DRUGStandard dose
Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 25(OH) vitamin D | Day 60 | Blood level of Vitamin D3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1,25(OH)2D vitamin D | Day 30 | Blood level of 1,25(OH)2D vitamin D |
| Urine Calcium | Day 30 | Calcium level in urine |
| Osteocalcin | Day 30 | Bone marker measured in blood |
| Beta-crosslaps | Day 30 | Bone marker measured in blood |
| Calcium | Day 60 | blood measurement |
| ionized calcium | Day 30 | blood measurement |
| 25(OH) vitamin D | Day 30 | Blood level of Vitamin D3 |
| phosphate | Day 60 | blood measurement |
| 60-day mortality | Day 60 | Number of patients who die in the specified timeframe |
| hospital stay | Day 60 | Hospital stay in days |
| hospital readmission | Day 60 | Number of readmissions |
| hepcidin | Day 30 | blood level marker for iron status |
| Quality of Life questionnaire | Day 30 | evaluated by EORTC questionnaire |
| creatinine | Day 30 | blood measurement |
Countries
Austria
Outcome results
None listed