High-dose Vitamin D3 in Pancreas Cancer

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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