Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants

Cairo University40 enrolled

Overview

This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.

Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent. Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance cellular immunity by increasing T regulatory cells is unknown. The effect of two different doses of vitamin D; 400 IU and 800 IU will be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Prematurity Immune Defect

Interventions

Vitamin DDRUG

Oral vitamin D

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm infants with gestational age 28-33 weeks Exclusion Criteria: * Necrotizing enterocolitis * Bowel perforation * Chromosomal anomalies * Inborn errors of metabolism * Major congenital anomalies

Outcomes

Primary Outcomes

Percent Change in The Number of T Regulatory Cells

Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells

Time frame: At 1 week (compared to baseline)

Percent Change in The Number of T Regulatory Cells

Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells

Time frame: At 4 weeks (compared to baseline)

Data from ClinicalTrials.gov

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