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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03793309
Collaborator
(none)
40
Enrollment
2
Arms
11
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants
Actual Study Start Date :
Jan 9, 2017
Actual Primary Completion Date :
Dec 11, 2017
Actual Study Completion Date :
Dec 11, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change in The Number of T Regulatory Cells [At 1 week (compared to baseline)]

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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lamiaa Mohsen, professor of Pediatrics, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03793309
    Other Study ID Numbers:
    • 12012016
    First Posted:
    Jan 4, 2019
    Last Update Posted:
    Jan 7, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth
    Vitamin D
    Ergocalciferols
    Cholecalciferol
    Vitamins

    Study Results

    No Results Posted as of Jan 7, 2019