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

Mansoura University Children Hospital

Status and phase: Completed; Phase 1

Conditions: Late-onset Sepsis; Prematurity

Treatments: Drug: High-dose vitamin D 3; Drug: Conventional-Dose Vitamin D 3

Study type: Interventional

Funder types: Other

Identifiers

NCT02273843

MS 306

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 3 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

High-dose vitamin D

Experimental group

Description:

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

Treatment:

Drug: High-dose vitamin D 3

Conventional-dose vitamin D

Active Comparator group

Description:

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

Treatment:

Drug: Conventional-Dose Vitamin D 3