High-dose Vitamin D3 in Pancreas Cancer

NCT03472833 | Terminated Phase 3

• 1 other identifier: VITdCUT 1.3 - 21022018
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

V

Outcome Measures

Primary Outcomes (1)

• 25(OH) vitamin D

  Blood level of Vitamin D3

  Day 60

Secondary Outcomes (24)

• 25(OH) vitamin D

  Day 30

• 1,25(OH)2D vitamin D

  Day 30

• 1,25(OH)2D vitamin D

  Day 60

• Urine Calcium

  Day 30

• Urine Calcium

  Day 60

Study Arms (2)

High-dose

EXPERIMENTAL

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.

Drug: High-dose

Standard-dose

ACTIVE COMPARATOR

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.

Drug: Standard dose

Interventions

High-dose 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

High-dose

Standard dose DRUG

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

Standard-dose

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both sexes
• vitamin D deficiency(≤20ng/ml)
• patients\>18 years of age
• pancreatic cancer
• surgical intervention/non-surgical intervention
• signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Peter Kornprat, Prof. Dr.

  Medical University of Graz, Departement for General Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: April 1, 2018
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-01

Locations

AU (1)