Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation

Outcome of High Dose Vitamin D on Prognosis of Sepsis Requiring Mechanical Ventilation; A Randomized Controlled Trial

There is a high prevalence of vitamin D deficiency in the critically ill patient population, with approximately 60% of patients found to be vitamin D deficient, (25(OH)D concentrations <20 ng/mL) and an additional 30% of patients being vitamin D insufficient, (25(OH)D = 20-30 ng/mL).Approximately 80% of sepsis/septic shock patients experience respiratory failure and require mechanical ventilation. Furthermore, several studies document that vitamin D deficiency could be associated with poor outcomes in critically ill patient.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: Vitamin D3 tablets; Drug: Vitamin D tablets

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain-Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with sepsis and required mechanical ventilation (MV) within 24 hours from ICU admission.
• Expected to require mechanical ventilation for at least 72 hours after study entry.

Exclusion Criteria:

• Age <18 years.
• inability to obtain informed consent from the patient and/or legally authorized representative.
• BMI> 40.
• Pregnant or breastfeeding.
• Chronic kidney diseases
• Pancreatitis.
• Hepatic insufficiency
• Cases with coagulopathy
• Moribund and not expected to survive 96 hours.
• Ongoing shock
• History of therapy with high dose vitamin D3 within previous 6 months.
• History of disorders associated with hypercalcemia
• Cancer as the cause of sepsis.
• Subjects undergoing chemotherapy.
• Immune compromised patients.
• Pneumonia developed < 48 hours following intubation.
• Patients with history of aspiration before intubation.
• known allergy to vitamin D.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1(Treatment group)	Drug: Vitamin D3 tablets; Vitamin D3 tablets 50,000 IU units
Active Comparator: Group 2(Control group)	Drug: Vitamin D tablets; Vitamin D tablets 5000 units as daily requirements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.	Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.	7 days

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: FMASU MS 47/ 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No