High-dose Vitamin D3 in Pancreas Cancer (VITdCUT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Quality of Life; Vitamin D Deficiency; Pancreas Cancer
• Intervention / Treatment: Drug: High-dose; Drug: Standard dose

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25(OH) vitamin D	Blood level of Vitamin D3	Day 60

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 20, 2021
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: V
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Pancreatic Diseases; Vitamin D Deficiency; Pancreatic Neoplasms
• Other Study ID Numbers: VITdCUT 1.3 - 21022018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No