High-dose Vitamin D3 in Pancreas Cancer

NCT ID: NCT03472833

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2021-04-20

Brief Summary

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

Pancreas Cancer; Vitamin D Deficiency; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

High-dose

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.

Group Type: EXPERIMENTAL

High-dose

Intervention Type: DRUG

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

Standard-dose

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.

Group Type: ACTIVE_COMPARATOR

Standard dose

Intervention Type: DRUG

Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days

Interventions

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 Type: DRUG

Standard dose

Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kornprat, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Departement for General Surgery

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

VITdCUT 1.3 - 21022018

Identifier Type: -

Identifier Source: org_study_id