Clinical trial · Interventional
High-dose Vitamin D3 in Pancreas Cancer
Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow recruitment, patients lost to follow-up due to Covid-19 pandemic.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose | Drug | — | UNRESOLVED |
| Standard dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-dose
- description
- 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.
- interventionNames
- Drug: High-dose
- type
- ACTIVE_COMPARATOR
- label
- Standard-dose
- description
- 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.
- interventionNames
- Drug: Standard dose
Primary outcomes (1)
- measure
- 25(OH) vitamin D
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available