JOURNAL ONKOLOGIE – STUDIE
VITdCUT High-dose Vitamin D3 in Pancreas Cancer
Rekrutierend
NCT-Nummer:
NCT03472833
Studienbeginn:
April 2018
Letztes Update:
14.09.2020
Wirkstoff:
High-dose, Standard dose
Indikation (Clinical Trials):
Vitamin D Deficiency, Pancreatic Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
Medical University of Graz
Collaborator:
-
Studienleiter
Principal Investigator
Medical University of Graz, Departement for General Surgery
Kontakt
Kontakt:
Phone: +4331638581548
E-Mail: erwin.mathew@medunigraz.at» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Medical University of Graz
8010 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Erwin Mathew, Dr. med.
Phone: +4331638581548
E-Mail: erwin.mathew@medunigraz.at» Ansprechpartner anzeigen
8010 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Erwin Mathew, Dr. med.
Phone: +4331638581548
E-Mail: erwin.mathew@medunigraz.at» Ansprechpartner anzeigen
Studien-Informationen
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.
Ein-/Ausschlusskriterien
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
Studien-Rationale
Primary outcome:1. 25(OH) vitamin D (Time Frame - Day 60):
Blood level of Vitamin D3
Secondary outcome:
1. 25(OH) vitamin D (Time Frame - Day 30):
Blood level of Vitamin D3
2. 1,25(OH)2D vitamin D (Time Frame - Day 30):
Blood level of 1,25(OH)2D vitamin D
3. 1,25(OH)2D vitamin D (Time Frame - Day 60):
Blood level of 1,25(OH)2D vitamin D
4. Urine Calcium (Time Frame - Day 30):
Calcium level in urine
5. Urine Calcium (Time Frame - Day 60):
Calcium level in urine
6. Osteocalcin (Time Frame - Day 30):
Bone marker measured in blood
7. Osteocalcin (Time Frame - Day 60):
Bone marker measured in blood
8. Beta-crosslaps (Time Frame - Day 30):
Bone marker measured in blood
9. Beta-crosslaps (Time Frame - Day 60):
Bone marker measured in blood
10. Calcium (Time Frame - Day 60):
blood measurement
11. Calcium (Time Frame - Day 30):
blood measurement
12. ionized calcium (Time Frame - Day 30):
blood measurement
13. ionized calcium (Time Frame - Day 60):
blood measurement
14. creatinine (Time Frame - Day 30):
blood measurement
15. creatinine (Time Frame - Day 60):
blood measurement
16. phosphate (Time Frame - Day 60):
blood measurement
17. phosphate (Time Frame - Day 30):
blood measurement
18. 60-day mortality (Time Frame - Day 60):
Number of patients who die in the specified timeframe
19. hospital stay (Time Frame - Day 60):
Hospital stay in days
20. hospital readmission (Time Frame - Day 60):
Number of readmissions
21. hepcidin (Time Frame - Day 30):
blood level marker for iron status
22. hepcidin (Time Frame - Day 60):
blood level marker for iron status
23. Quality of Life questionnaire (Time Frame - Day 30):
evaluated by EORTC questionnaire
24. Quality of Life questionnaire (Time Frame - Day 60):
evaluated by EORTC questionnaire
Studien-Arme
- 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. - 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.
Geprüfte Regime
- High-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 - Standard dose:
Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days
Quelle: ClinicalTrials.gov
