NCT05969327

Role of Vitamin D Therapy in Recovery From Early Neonatal Sepsis (Randomized Controlled Trial)

Completed Phase 3 Last updated 24 August 2023

What this trial tests

Phase 3 trial testing Vitamin D in Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis in 66 participants. Completed in 27 December 2022.

Timeline

14 August 2018

Primary endpoint
6 September 2022

27 December 2022

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	66
Start date	14 August 2018
Primary completion	6 September 2022
Estimated completion	27 December 2022
Sites	1 location across Egypt

Drugs / interventions tested

• Vitamin D

Conditions studied

• Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis — all drugs for Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis →

Sponsor

Ain Shams University

Who can join

Adults 3 Days to 7 Days, any sex, with Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neonatal sepsis is still a major cause of morbidity and mortality despite major advances in neonatal intensive care units. Early-onset sepsis (EOS) is an infection of the blood acquired vertically from the mother and manifests shortly after birth. The objective of this study is to assess the vitamin D status in neonates with Early onset sepsis (EOS) and evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), in these infants.

Publications & conference data

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