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

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.

Completed

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Immune Defect Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Oral vitamin D

Other names: Oral vitamin D

Primary outcomes

Percent Change in The Number of T Regulatory Cells

Time frame: At 1 week (compared to baseline)

Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells
Percent Change in The Number of T Regulatory Cells

Time frame: At 4 weeks (compared to baseline)

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 4, 2019
Registry last updated: Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed