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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793309
• Other study ID #: 12012016
• Status: Completed
• Phase: Phase 1
• Start date: January 9, 2017
• Est. completion date: December 11, 2017

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Immune Defect
• Prematurity

Intervention

Drug:
• Vitamin D
Oral vitamin D

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. 201 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At 1 week (compared to baseline)
Primary	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	At 4 weeks (compared to baseline)