VITdCUT: High-dose Vitamin D3 in Pancreas Cancer

Sponsor

Medical University of Graz (Other)

Overall Status

Terminated

CT.gov ID

NCT03472833

Collaborator

(none)

Enrollment

Location

Arms

36.6

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer Vitamin D Deficiency Quality of Life	Drug: High-dose Drug: Standard dose	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Apr 20, 2021

Actual Study Completion Date :

Apr 20, 2021

Arms and Interventions

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 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
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 Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days

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

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

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

Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days

Outcome Measures

Primary Outcome Measures

25(OH) vitamin D [Day 60]
Blood level of Vitamin D3

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Styria	Austria	8010

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator: Peter Kornprat, Prof. Dr., Medical University of Graz, Departement for General Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT03472833

Other Study ID Numbers:

VITdCUT 1.3 - 21022018

First Posted:

Mar 21, 2018

Last Update Posted:

Feb 15, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Graz

Additional relevant MeSH terms:

Pancreatic Neoplasms

Vitamin D Deficiency

Study Results

No Results Posted as of Feb 15, 2022