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Impact of Vitamin D Supplementation on Hepcidin Levels and Transfusion Requirements in Surgical and Septic Patients

NCT03001687 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-02-06

No results posted yet for this study

Summary

Acute inflammation induced by surgery and sepsis is complicated by the development of iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin might be a potential target to reduce transfusion requirements in surgical and sepsis patients. Vitamin D supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that by using vitamin D supplementation in surgical and septic shock patients, the physicians could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a randomised controlled trial to determine the impact of high-dose vitamin D enteral supplementation on serum hepcidin levels and transfusion requirements after major abdominal surgery and in septic shock patients.

Conditions

  • Systemic Inflammatory Response Syndrome
  • Sepsis
  • Surgical Injuries

Interventions

DIETARY_SUPPLEMENT

enteral supplementation with vitamin D

Patients allocated to the "vitamin D +" group receive enteral supplementation with high-dose vitamin D (250.000UI)

OTHER

blood collection 3mL

all patients will have hepcidin levels measured in the first 24 hours after admission and one week after

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Cristina Petrisor, MD, PhD · University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • Romania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001687 on ClinicalTrials.gov