NCT02273843

A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mansoura University Children Hospital · Academic / Other
• Sex: All
• Age: 3 Days – 28 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will 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 we will also evaluate their safety and influence on clinical outcomes of these infants

Conditions

• Prematurity
• Late-onset Sepsis

Interventions

Type	Name	Description
DRUG	High-dose vitamin D 3	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
DRUG	Conventional-Dose Vitamin D 3	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

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-10-24
• Last updated: 2015-09-30

Locations

1 site across 1 country: Egypt