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Register:	ClinicalTrials.gov
Last refreshed on:	21 February 2022
Main ID:	NCT03472833
Date of registration:	14/03/2018
Prospective Registration:	Yes
Primary sponsor:	Medical University of Graz
Public title:	High-dose Vitamin D3 in Pancreas Cancer VITdCUT
Scientific title:	Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study
Date of first enrolment:	April 1, 2018
Target sample size:	25
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT03472833
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Austria

Contacts

Name:	Peter Kornprat, Prof. Dr.
Address:
Telephone:
Email:
Affiliation:	Medical University of Graz, Departement for General Surgery

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pancreas Cancer

Quality of Life

Vitamin D Deficiency

Intervention(s)

Drug: High-dose

Drug: Standard dose

Primary Outcome(s)

25(OH) vitamin D [Time Frame: Day 60]

Secondary Outcome(s)

creatinine [Time Frame: Day 60]

Osteocalcin [Time Frame: Day 60]

phosphate [Time Frame: Day 30]

Urine Calcium [Time Frame: Day 30]

25(OH) vitamin D [Time Frame: Day 30]

Calcium [Time Frame: Day 60]

hepcidin [Time Frame: Day 60]

1,25(OH)2D vitamin D [Time Frame: Day 30]

ionized calcium [Time Frame: Day 30]

1,25(OH)2D vitamin D [Time Frame: Day 60]

Calcium [Time Frame: Day 30]

ionized calcium [Time Frame: Day 60]

Quality of Life questionnaire [Time Frame: Day 30]

Beta-crosslaps [Time Frame: Day 60]

phosphate [Time Frame: Day 60]

Quality of Life questionnaire [Time Frame: Day 60]

Osteocalcin [Time Frame: Day 30]

creatinine [Time Frame: Day 30]

hepcidin [Time Frame: Day 30]

Urine Calcium [Time Frame: Day 60]

60-day mortality [Time Frame: Day 60]

Beta-crosslaps [Time Frame: Day 30]

hospital readmission [Time Frame: Day 60]

hospital stay [Time Frame: Day 60]

Secondary ID(s)

VITdCUT 1.3 - 21022018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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