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

Phase 1

Completed

• Conditions: Prematurity; Late-onset Sepsis
• Interventions: Drug: High-dose vitamin D 3; Drug: Conventional-Dose Vitamin D 3

• Registration Number: NCT02273843
• Lead Sponsor: Mansoura University Children Hospital

Brief 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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Preterm Infants (28-37 wk gestational age)

• Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:

  1. Temperature instability (hypothermia, hyperthermia);
  2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  3. Neurologic (hypotonia, lethargy, seizures);
  4. Gastrointestinal (feeding intolerance, abdominal distension).

Exclusion Criteria

• Major congenital anomalies.
• Chromosomal anomalies.
• Known inborn error(s) of metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose vitamin D	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
Conventional-dose vitamin D	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

Primary Outcome Measures

Name	Time	Method
Serum interleukin-6	At trial entry and 7 days after daily vitamin D supplementation therapy	Serum levels of interleukin-6 (IL-6) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy. IL-6 concentrations will be determined by Endogenous Interleukin-ELISA
Serum tumor necrosis-alpha	At trial entry and 7 days after daily vitamin D supplementation therapy	Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy

Secondary Outcome Measures

Name	Time	Method
Serum C-reactive protein (CRP)	At trial entery and 7 days after daily vitamin D supplementation therapy	Serum CRP will be evaluated at enrollment and 7 days
Serum 25(OH)D levels	at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age	Serum 25(OH)D levels will be measured by ELISA at trial entry, at day 7 and at 40 weeks postmenstrual age
Serum calcium, phosphorus and urinary calcium	Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks	Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks
Neonatal morbidities	Participants will be followed for the duration of hospital stay, for an expected average of 4 weeks	Participants will be followed for the duration of hospital stay, for an expected average of 5 weeks and the incidence of neonatal morbidities e.g. NEC, retinopathy of prematurity, disseminated intravascular coagulopathy and renal dysfunction will be assessed
Abdominal ultrasonography	40 weeks postmenstrual age	Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age
Mortality	Baseline	In-hospital mortality during NICU admission for an expected average of 5 weeks

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Mansoura University Children Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt