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

NCT03001687 | Unknown

• 1 other identifier: 434/24.11.2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hepcidin; sepsis; surgery; vitamin D

Outcome Measures

Primary Outcomes (1)

• Hepcidin concentration (ng/mL)

  Hepcidin serum concentrations measured one week after the intervention

  one week after intervention

Secondary Outcomes (1)

• Number of Packed red cells

  two weeks after intervention

Study Arms (2)

vitamin D +

EXPERIMENTAL

Patients in the "vitamin D" group will receive enteral supplementation with vitamin D, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement

Dietary Supplement: enteral supplementation with vitamin D; Other: blood collection 3mL

vitamin D -

PLACEBO COMPARATOR

Patients in "vitamin D -" group do not receive enteral supplementation with vitamin D and represent the control group, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement

Other: blood collection 3mL

Interventions

enteral supplementation with vitamin D DIETARY_SUPPLEMENT

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

vitamin D +

blood collection 3mL OTHER

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

vitamin D +; vitamin D -

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• sepsis and septic shock patients
• patients with major abdominal surgery

You may not qualify if:

• chronic inflammatory conditions (chronic kidney disease, hematologic, and rheumatic/autoimmune disease)
• morbid obesity (BMI over 40kg/m2)
• pregnancy and lactation
• hypercalcemia (total calcium\> 10.6mg/dL, serum ionized calcium\>5.4mg/dL)
• tuberculosis, sarcoidosis
• nephrolithiasis
• recent history of vitamin D supplementation or erythropoietin

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

Cluj-Napoca, Cluj, 400012, Romania

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis; Intraoperative Complications

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Cristina Petrisor, MD, PhD

  University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luminita Goga

CONTACT

+40-264-597-256; contact@umfcluj.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 6, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)