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Trial record 67 of 108 for:    CALCIUM CATION

High-dose Vitamin D3 in Pancreas Cancer (VITdCUT)

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ClinicalTrials.gov Identifier: NCT03472833
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Vitamin D Deficiency Quality of Life Drug: High-dose Drug: Standard dose Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Drug: 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

Active Comparator: 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.

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




Primary Outcome Measures :
  1. 25(OH) vitamin D [ Time Frame: Day 60 ]
    Blood level of Vitamin D3


Secondary Outcome Measures :
  1. 25(OH) vitamin D [ Time Frame: Day 30 ]
    Blood level of Vitamin D3

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

  3. 1,25(OH)2D vitamin D [ Time Frame: Day 60 ]
    Blood level of 1,25(OH)2D vitamin D

  4. Urine Calcium [ Time Frame: Day 30 ]
    Calcium level in urine

  5. Urine Calcium [ Time Frame: Day 60 ]
    Calcium level in urine

  6. Osteocalcin [ Time Frame: Day 30 ]
    Bone marker measured in blood

  7. Osteocalcin [ Time Frame: Day 60 ]
    Bone marker measured in blood

  8. Beta-crosslaps [ Time Frame: Day 30 ]
    Bone marker measured in blood

  9. Beta-crosslaps [ Time Frame: Day 60 ]
    Bone marker measured in blood

  10. Calcium [ Time Frame: Day 60 ]
    blood measurement

  11. Calcium [ Time Frame: Day 30 ]
    blood measurement

  12. ionized calcium [ Time Frame: Day 30 ]
    blood measurement

  13. ionized calcium [ Time Frame: Day 60 ]
    blood measurement

  14. creatinine [ Time Frame: Day 30 ]
    blood measurement

  15. creatinine [ Time Frame: Day 60 ]
    blood measurement

  16. phosphate [ Time Frame: Day 60 ]
    blood measurement

  17. phosphate [ Time Frame: Day 30 ]
    blood measurement

  18. 60-day mortality [ Time Frame: Day 60 ]
    Number of patients who die in the specified timeframe

  19. hospital stay [ Time Frame: Day 60 ]
    Hospital stay in days

  20. hospital readmission [ Time Frame: Day 60 ]
    Number of readmissions

  21. hepcidin [ Time Frame: Day 30 ]
    blood level marker for iron status

  22. hepcidin [ Time Frame: Day 60 ]
    blood level marker for iron status

  23. Quality of Life questionnaire [ Time Frame: Day 30 ]
    evaluated by EORTC questionnaire

  24. Quality of Life questionnaire [ Time Frame: Day 60 ]
    evaluated by EORTC questionnaire



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472833


Contacts
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Contact: Erwin Mathew, Dr. med. +4331638581548 erwin.mathew@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Styria, Austria, 8010
Contact: Erwin Mathew, Dr. med.    +4331638581548    erwin.mathew@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Peter Kornprat, Prof. Dr. Medical University of Graz, Departement for General Surgery

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03472833     History of Changes
Other Study ID Numbers: VITdCUT 1.3 - 21022018
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Graz:
V
Additional relevant MeSH terms:
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Calcium-Regulating Hormones and Agents
Pancreatic Neoplasms
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents