High-dose Vitamin D3 in Pancreas Cancer

Phase 3

Terminated

• Conditions: Vitamin D Deficiency; Quality of Life; Pancreas Cancer
• Interventions: Drug: Standard dose; Drug: High-dose

• Registration Number: NCT03472833
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-21
• Study Start: 2018-04-01
• Primary Completion: 2021-04-20
• Study Completion: 2021-04-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-dose	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.
High-dose	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.

Primary Outcome Measures

Name	Time	Method
25(OH) vitamin D	Day 60	Blood level of Vitamin D3

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria