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

Phase 1

Completed

• Conditions: Immune Defect; Prematurity
• Interventions: Drug: Vitamin D

• Registration Number: NCT03793309
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2017-01-09
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Study First Submitted: 2018-12-24
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	Vitamin D	Subjects in this group receive 400 IU vitamin D daily for 4 weeks.
High dose	Vitamin D	Subjects in this group receive 800 IU vitamin D daily for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Percent Change in The Number of T Regulatory Cells	At 4 weeks (compared to baseline)	Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells