NCT05244018

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

Completed Phase 4 Last updated 7 November 2022

What this trial tests

Phase 4 trial testing Vitamin D3 tablets in Sepsis in 80 participants. Completed in 31 October 2022.

Timeline

1 March 2022

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 March 2022
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Vitamin D3 tablets — full drug profile →
• Vitamin D tablets — full drug profile →

Conditions studied

• Sepsis — all drugs for Sepsis →

Sponsor

Ain Shams University

Who can join

18 and older, any sex, with Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.