High-dose vitamin D3 in pancreas cancer

Influence of high dose vitamin D3 intake on outcome in pancreatic cancer surgery: prospective, randomized, open, controlled study - The VITDCUT Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003489-28-AT

Enrollment

Registered

2018-02-13

Start date

2018-02-19

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vitamin D deficiency - pancreatic cancer

Interventions

Trade Name: Oleovit Pharmaceutical Form: Oral liquid INN or Proposed INN: COLECALCIFEROL Other descriptive name: Coecalciferol_Vitamin D3_oily formulation Concentration unit: ml millilitre(s) Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • both sexes • vitamin D deficiency ( 18 years of age • pancreatic Cancer • surgical intervention/non-surgical Intervention • signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: • patients 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) • normal vitamin D serum levels metastasized pancreatic Cancer missing written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate that a high dose vitamin D supplementation leads to a higher 25(OH) vitamin D blood level versus the standard supplementation in pancreatic cancer patients-Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL);Secondary Objective: 25(OH) vitamin D blood level on day 30 • 1,25(OH)2D on day 30 and day 60 • urine calcium on day 30 and day 60 • 60-day mortality • hospital stay • hospital readmission • hepcidin blood level correlation to 25(OH)D • EORTC QLQ-PAN 26 questionnaire ;Primary end point(s): Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL);Timepoint(s) of evaluation of this end point: day 60	—

Measure

Time frame

Main Objective: Evaluate that a high dose vitamin D supplementation leads to a higher 25(OH) vitamin D blood level versus the standard supplementation in pancreatic cancer patients-Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL);Secondary Objective: 25(OH) vitamin D blood level on day 30 • 1,25(OH)2D on day 30 and day 60 • urine calcium on day 30 and day 60 • 60-day mortality • hospital stay • hospital readmission • hepcidin blood level correlation to 25(OH)D • EORTC QLQ-PAN 26 questionnaire ;Primary end point(s): Normalization 25(OH) vitamin D blood level on day 60 (>75ng/mL);Timepoint(s) of evaluation of this end point: day 60

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Secondary

Measure	Time frame
Secondary end point(s): • 25(OH) vitamin D blood level on day 30 • 1,25(OH)2D on day 30 and day 60 • urine calcium on day 30 and day 60 • Osteocalcin on day 30 and day 60 • Beta-crosslaps on day 30 and day 60 • Calcium, ionized calcium, creatinine, phosphate on day 30 and day 60 • 60-day mortality • hospital stay • hospital readmission • hepcidin blood level on day 30 and day 60 • EORTC QLQ-PAN 26 questionnaire on day 30 and day 60 ;Timepoint(s) of evaluation of this end point: day 30 and day 60	—

Measure

Time frame

Secondary end point(s): • 25(OH) vitamin D blood level on day 30 • 1,25(OH)2D on day 30 and day 60 • urine calcium on day 30 and day 60 • Osteocalcin on day 30 and day 60 • Beta-crosslaps on day 30 and day 60 • Calcium, ionized calcium, creatinine, phosphate on day 30 and day 60 • 60-day mortality • hospital stay • hospital readmission • hepcidin blood level on day 30 and day 60 • EORTC QLQ-PAN 26 questionnaire on day 30 and day 60 ;Timepoint(s) of evaluation of this end point: day 30 and day 60

—

Countries

Austria

Contacts

Public ContactKKS Medizinische Universität Graz

Medizinische Universität Graz

astrid.friedel@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026