TerminatedNCT03472833VITdCUTUpdated Feb 15, 2022

High-dose Vitamin D3 in Pancreas Cancer

A Phase 3 interventional study of High-dose and Standard dose in Pancreas Cancer, Vitamin D Deficiency and Quality of Life, sponsored by Medical University of Graz. Terminated at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Medical University of Graz · Phase 3, Interventional, and Supportive care

Why this study was terminated

slow recruitment, patients lost to follow-up due to Covid-19 pandemic.

Phase: Phase 3
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study 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.

Conditions studied

Pancreas Cancer
Vitamin D Deficiency
Quality of Life

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Keywords

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's enrollment of 25 is below the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

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Lead sponsor

Medical University of Graz is the lead sponsor of 470 studies on the registry; 98 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 25 participants (actual)

Study arms

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
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

Interventions

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

What researchers measure

Primary outcomes

25(OH) vitamin D
Blood level of Vitamin D3
Time frame: Day 60

Secondary outcomes

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

Study locations

1 site

Medical University of Graz
Graz, Styria 8010, Austria

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Apr 2021, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 14, 2018
First posted: Mar 21, 2018
StartActual: Apr 1, 2018
Primary completionActual: Apr 20, 2021
CompletionActual: Apr 20, 2021
Last update: Feb 15, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03472833
Lead sponsor: Medical University of Graz
Responsible party: Sponsor
First posted: Mar 21, 2018
Start date: Apr 1, 2018
Primary completion: Apr 20, 2021
Completion: Apr 20, 2021
Last update: Feb 15, 2022

Study contacts

Peter Kornprat, Prof. Dr.

principal investigator · Medical University of Graz, Departement for General Surgery

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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