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

Phase 4

Completed

• Conditions: Sepsis
• Interventions: Drug: Vitamin D3 tablets; Drug: Vitamin D tablets

• Registration Number: NCT05244018
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-29
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-17
• Study Start: 2022-03-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1(Treatment group)	Vitamin D3 tablets	-
Group 2(Control group)	Vitamin D tablets	-

Primary Outcome Measures

Name	Time	Method
Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.	7 days	Change in procalcitonin level (ng/ml) and antimicrobial peptide cathelicidin (LL37) (ng/ml) level at day 7.

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt