2018-04-01
2021-04-20
2021-04-20
25
NCT03472833
Medical University of Graz
Medical University of Graz
INTERVENTIONAL
High-dose Vitamin D3 in Pancreas Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-03-14 | N/A | 2022-01-31 |
2018-03-14 | N/A | 2022-02-15 |
2018-03-21 | N/A | 2022-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: High-dose 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
|
| ACTIVE_COMPARATOR: Standard-dose 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 25(OH) vitamin D | Blood level of Vitamin D3 | Day 60 |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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