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

Cairo University (CU)

Status and phase: Completed; Phase 1

Conditions: Prematurity; Immune Defect

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03793309

12012016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 28 days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Low dose

Experimental group

Description:

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

Treatment:

Drug: Vitamin D

High dose

Experimental group

Description:

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

Treatment:

Drug: Vitamin D