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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03793309

Enrollment

Registered

2019-01-04

Start date

2017-01-09

Completion date

2017-12-11

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Defect, Prematurity

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.

Interventions

DRUGVitamin D

Oral vitamin D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026