NCT05969327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 24, 2023

Status Verified

December 1, 2017

Enrollment Period

4.1 years

First QC Date

July 23, 2023

Last Update Submit

August 22, 2023

Conditions

Importance of Vitamin D Therapy in Treatment of Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

  • Role of Vitamin D therapy in recovery from Early Neonatal Sepsis (randomized controlled trial)

    supplementation of Vitamin D

    nearly 4 years

Study Arms (3)

with out vitamin D

NO INTERVENTION

neonates without supplementation

Vitamin D 400 IU

EXPERIMENTAL

neonates with 400 IU supplementation

Drug: Vitamin D

Vitamin D 800 IU

EXPERIMENTAL

neonates with 800 IU supplementation

Drug: Vitamin D

Interventions

Vitamin DDRUG

oral supplementation of two different doses

Vitamin D 400 IUVitamin D 800 IU

Eligibility Criteria

Age3 Days - 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Preterm newborn, NPO neonates , infants with maternal risk factors , such as clinical and/or histological chorioamnionitis, neonates delivered at home ,neonates to mothers with premature rupture of membrane, and major congenital abnormalities which may be predisposing factors for development of EOS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayada Ahmad Mohamed

Zagazig, Egypt

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

August 14, 2018

Primary Completion

September 6, 2022

Study Completion

December 27, 2022

Last Updated

August 24, 2023

Record last verified: 2017-12

Locations

EG(1)