High-dose Vitamin D3 in Pancreas Cancer (VITdCUT)

Medical University of Graz

Status and phase: Terminated; Phase 3

Conditions: Quality of Life; Vitamin D Deficiency; Pancreas Cancer

Treatments: Drug: Standard dose; Drug: High-dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03472833

VITdCUT 1.3 - 21022018

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

High-dose

Experimental group

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.

Treatment:

Drug: High-dose

Standard-dose

Active Comparator group

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.

Treatment:

Drug: Standard dose