Pancreas CancerPhase 3VITdCUTNCT03472833
High-dose Vitamin D3 in Pancreas Cancer
A Phase 3 study testing High-dose and Standard dose in people with Pancreas Cancer and Vitamin D Deficiency, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreas Cancer, Vitamin D Deficiency, Quality of Life
- What is being tested?
- High-dose and Standard dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2018to 20 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes
- vitamin D deficiency(≤20ng/ml)
- patients>18 years of age
- pancreatic cancer
- surgical intervention/non-surgical intervention
- signed written informed consent
Who cannot join
- 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)
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- metastasized pancreatic cancer
- normal vitamin D serum levels
- missing written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pancreas Cancer, Vitamin D Deficiency, Quality of Life
- Being tested
- High-dose, Standard dose
- Keywords
- V
- Medical subject headings
- Pancreatic Neoplasms, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-doseDrug
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 doseDrug
Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days
| Study group | Role | What they receive |
|---|---|---|
| High-dose | Experimental | 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. Receives: Drug: High-dose |
| Standard-dose | Active comparator | 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. Receives: Drug: Standard dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH) vitamin D
Blood level of Vitamin D3
Measured: Day 60
Secondary outcomes (24)
25(OH) vitamin D
Blood level of Vitamin D3
Measured: Day 30
1,25(OH)2D vitamin D
Blood level of 1,25(OH)2D vitamin D
Measured: Day 30
1,25(OH)2D vitamin D
Blood level of 1,25(OH)2D vitamin D
Measured: Day 60
Urine Calcium
Calcium level in urine
Measured: Day 30
Urine Calcium
Calcium level in urine
Measured: Day 60
Osteocalcin
Bone marker measured in blood
Measured: Day 30
Osteocalcin
Bone marker measured in blood
Measured: Day 60
Beta-crosslaps
Bone marker measured in blood
Measured: Day 30
Beta-crosslaps
Bone marker measured in blood
Measured: Day 60
Calcium
blood measurement
Measured: Day 60
Calcium
blood measurement
Measured: Day 30
ionized calcium
blood measurement
Measured: Day 30
ionized calcium
blood measurement
Measured: Day 60
creatinine
blood measurement
Measured: Day 30
creatinine
blood measurement
Measured: Day 60
phosphate
blood measurement
Measured: Day 60
phosphate
blood measurement
Measured: Day 30
60-day mortality
Number of patients who die in the specified timeframe
Measured: Day 60
hospital stay
Hospital stay in days
Measured: Day 60
hospital readmission
Number of readmissions
Measured: Day 60
hepcidin
blood level marker for iron status
Measured: Day 30
hepcidin
blood level marker for iron status
Measured: Day 60
Quality of Life questionnaire
evaluated by EORTC questionnaire
Measured: Day 30
Quality of Life questionnaire
evaluated by EORTC questionnaire
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Apr 2018
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Why it stopped: slow recruitment, patients lost to follow-up due to Covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kornprat, Prof. Dr., Principal investigator, Medical University of Graz, Departement for General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472833
- Sponsor's protocol ID
- VITdCUT 1.3 - 21022018
- Acronym
- VITdCUT
- Status last verified
- Jan 2022
- First submitted
- 14 Mar 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03472833
- Acronym / sponsor ID
- VITdCUT / VITdCUT 1.3 - 21022018
- Conditions
- Pancreas Cancer, Vitamin D Deficiency, Quality of Life
- Keywords
- V
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment, patients lost to follow-up due to Covid-19 pandemic.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose | Experimental | Drug: High-doseIntervention 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. |
| Standard-dose | Active comparator | Drug: Standard doseIntervention 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- both sexes
- vitamin D deficiency(≤20ng/ml)
- patients>18 years of age
- pancreatic cancer
- surgical intervention/non-surgical intervention
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dosePatients 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 | Drug | High-dose |
| Standard dosePatients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days | Drug | Standard-dose |
Primary outcome
25(OH) vitamin D
Time frame: Day 60
Blood level of Vitamin D3
24 secondary outcomes
25(OH) vitamin D
Time frame: Day 30
1,25(OH)2D vitamin D
Time frame: Day 30
1,25(OH)2D vitamin D
Time frame: Day 60
Urine Calcium
Time frame: Day 30
Urine Calcium
Time frame: Day 60
Osteocalcin
Time frame: Day 30
Osteocalcin
Time frame: Day 60
Beta-crosslaps
Time frame: Day 30
Beta-crosslaps
Time frame: Day 60
Calcium
Time frame: Day 60
Calcium
Time frame: Day 30
ionized calcium
Time frame: Day 30
ionized calcium
Time frame: Day 60
creatinine
Time frame: Day 30
creatinine
Time frame: Day 60
phosphate
Time frame: Day 60
phosphate
Time frame: Day 30
60-day mortality
Time frame: Day 60
hospital stay
Time frame: Day 60
hospital readmission
Time frame: Day 60
hepcidin
Time frame: Day 30
hepcidin
Time frame: Day 60
Quality of Life questionnaire
Time frame: Day 30
Quality of Life questionnaire
Time frame: Day 60
Results and safety
The study was stopped early (reason given: slow recruitment, patients lost to follow-up due to Covid-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kornprat, Prof. Dr. principal investigator
Medical University of Graz, Departement for General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High-dose and Standard dose in people with Pancreas Cancer and Vitamin D Deficiency, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment, patients lost to follow-up due to Covid-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25(OH) vitamin D (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.