High-dose Vitamin D3 in Pancreas Cancer
The registry record from ClinicalTrials.gov (public domain): summary, interventions, outcomes and eligibility. Questions are answered only with quotes from this document. Source: ClinicalTrials.gov, retrieved 2026-11-05.
Stopped earlyWhy stopped, per the registry: “slow recruitment, patients lost to follow-up due to Covid-19 pandemic.”
Record metadata
- Phase
- Phase 3
- Status
- Terminated
- Start
- 2018-04-01
- End
- 2021-04-20
- Enrollment
- 25
- Sites
- 1
- Sponsor class
- OTHER
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Source text
Brief summary · public domain (ClinicalTrials.gov) · T1
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.
Intervention · public domain (ClinicalTrials.gov) · T1
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
Intervention · public domain (ClinicalTrials.gov) · T1
Drug: Standard dose. Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days
Arm · public domain (ClinicalTrials.gov) · T1
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.
Arm · public domain (ClinicalTrials.gov) · T1
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.
Primary outcome · public domain (ClinicalTrials.gov) · T1
25(OH) vitamin D. Blood level of Vitamin D3 Time frame: Day 60.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
25(OH) vitamin D. Time frame: Day 30.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
1,25(OH)2D vitamin D. Time frame: Day 30.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
1,25(OH)2D vitamin D. Time frame: Day 60.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Urine Calcium. Time frame: Day 30.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Urine Calcium. Time frame: Day 60.
Secondary outcome · public domain (ClinicalTrials.gov) · T1
Osteocalcin. Time frame: Day 30.
Eligibility · public domain (ClinicalTrials.gov) · T1
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
Enrollment · public domain (ClinicalTrials.gov) · T1
Enrollment: 25 participants (actual).
Why stopped · public domain (ClinicalTrials.gov) · T1
slow recruitment, patients lost to follow-up due to Covid-19 pandemic.