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slow recruitment, patients lost to follow-up due to Covid-19 pandemic.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose | Experimental | 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. |
|
| Standard-dose | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25(OH) vitamin D | Blood level of Vitamin D3 | Day 60 |
| 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 |
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Inclusion Criteria:
both sexes
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kornprat, Prof. Dr. | Medical University of Graz, Departement for General Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | Styria | 8010 | Austria |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Standard dose | Drug | Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days |
|
| 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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |