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

Primary Purpose

Prematurity, Immune Defect

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional treatment trial for Prematurity

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low dose

High dose

Arm Description

Subjects in this group receive 400 IU vitamin D daily for 4 weeks.

Subjects in this group receive 800 IU vitamin D daily for 4 weeks.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03793309

First Posted

December 24, 2018

Last Updated

January 3, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03793309

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 9, 2017 (Actual)

Primary Completion Date

December 11, 2017 (Actual)

Study Completion Date

December 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity, Immune Defect

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose

Arm Type

Experimental

Arm Description

Subjects in this group receive 400 IU vitamin D daily for 4 weeks.

Arm Title

High dose

Arm Type

Experimental

Arm Description

Subjects in this group receive 800 IU vitamin D daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Oral vitamin D

Intervention Description

Oral vitamin D

Primary Outcome Measure Information:

Title

Percent Change in The Number of T Regulatory Cells

Description

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)

Title

Percent Change in The Number of T Regulatory Cells

Description

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)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lamiaa Mohsen, MD

Organizational Affiliation

Cairo University Children's Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28779655

Citation

Bozkurt O, Uras N, Sari FN, Atay FY, Sahin S, Alkan AD, Canpolat FE, Oguz SS. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. Early Hum Dev. 2017 Sep;112:54-59. doi: 10.1016/j.earlhumdev.2017.07.016. Epub 2017 Aug 2.

Results Reference

result

PubMed Identifier

15209957

Citation

Zittermann A, Dembinski J, Stehle P. Low vitamin D status is associated with low cord blood levels of the immunosuppressive cytokine interleukin-10. Pediatr Allergy Immunol. 2004 Jun;15(3):242-6. doi: 10.1111/j.1399-3038.2004.00140.x.

Results Reference

result

PubMed Identifier

33305842

Citation

Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

Results Reference

derived

PubMed Identifier

31335838

Citation

Aly H, Mohsen L, Bhattacharjee I, Malash A, Atyia A, Elanwary S, El Hawary R. Vitamin D Supplementation and T Cell Regulation in Preterm Infants: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Nov;69(5):607-610. doi: 10.1097/MPG.0000000000002448.

Results Reference

derived

Learn more about this trial

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

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