High-dose Vitamin D3 in Pancreas Cancer

Quality of Life Clinical Trial

— VITdCUT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03472833
• Other study ID #: VITdCUT 1.3 - 21022018
• Status: Terminated
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: April 20, 2021

Study information

• Verified date: January 2022
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms
• Quality of Life
• Vitamin D Deficiency

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

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