High-dose Vitamin D3 in Pancreas Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study

Conditions
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Pancreas Cancer, Vitamin D Deficiency, Quality of Life

Intervention / Treatment
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* Drug: High-dose
* Drug: Standard dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose<br>Intervention with high dose oral vitamin D3 supplementation. 1 drop equals 400 I.U. This group will get 180.000 I.U. on day 1, and then 4000 I.U. per day for 60 days. | Drug: High-dose<br>* 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<br>|
| Active Comparator: Standard-dose<br>Intervention with standard dose oral vitamin D3 supplementation. 1 drop equals 400 I.U. This group will get 800 I.U. per day for 60 days. | Drug: Standard dose<br>* Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH) vitamin D | Blood level of Vitamin D3 | Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25(OH) vitamin D | Blood level of Vitamin D3 | Day 30 | 
| 1,25(OH)2D vitamin D | Blood level of 1,25(OH)2D vitamin D | Day 30 | 
| 1,25(OH)2D vitamin D | Blood level of 1,25(OH)2D vitamin D | Day 60 | 
| Urine Calcium | Calcium level in urine | Day 30 | 
| Urine Calcium | Calcium level in urine | Day 60 | 
| Osteocalcin | Bone marker measured in blood | Day 30 | 
| Osteocalcin | Bone marker measured in blood | Day 60 | 
| Beta-crosslaps | Bone marker measured in blood | Day 30 | 
| Beta-crosslaps | Bone marker measured in blood | Day 60 | 
| Calcium | blood measurement | Day 60 | 
| Calcium | blood measurement | Day 30 | 
| ionized calcium | blood measurement | Day 30 | 
| ionized calcium | blood measurement | Day 60 | 
| creatinine | blood measurement | Day 30 | 
| creatinine | blood measurement | Day 60 | 
| phosphate | blood measurement | Day 60 | 
| phosphate | blood measurement | Day 30 | 
| 60-day mortality | Number of patients who die in the specified timeframe | Day 60 | 
| hospital stay | Hospital stay in days | Day 60 | 
| hospital readmission | Number of readmissions | Day 60 | 
| hepcidin | blood level marker for iron status | Day 30 | 
| hepcidin | blood level marker for iron status | Day 60 | 
| Quality of Life questionnaire | evaluated by EORTC questionnaire | Day 30 | 
| Quality of Life questionnaire | evaluated by EORTC questionnaire | Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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