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

January 3, 2019 updated by: Lamiaa Mohsen, Cairo University

A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
Subjects in this group receive 400 IU vitamin D daily for 4 weeks.
Drug: Vitamin D
Oral vitamin D
Other Names:
  • Oral vitamin D
Experimental: High dose
Subjects in this group receive 800 IU vitamin D daily for 4 weeks.
Drug: Vitamin D
Oral vitamin D
Other Names:
  • Oral vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 1 week (compared to baseline)
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
At 4 weeks (compared to baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Lamiaa Mohsen, MD, Cairo University Children'S Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2017

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12012016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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