CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
High-dose vitamin D 3 +1 moredrug
Likely dose
High-dose vitamin D 3 800 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02273843
NCT02273843Phase 1Completed
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Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis

Mansoura University Children Hospital·interventional·Posted Oct 24, 2014·Updated Sep 30, 2015

In Brief

A Phase 1 clinical trial evaluating High-dose vitamin D 3 and Conventional-Dose Vitamin D 3 for Prematurity and Late-onset Sepsis. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrematurity, Late-onset Sepsis
CountriesEgypt
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 24, 2014
Enrollment StartSep 1, 2013
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.7 years ago

Interventions

High-dose vitamin D 3drug

Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU

Conventional-Dose Vitamin D 3drug

Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU