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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03793309
Other study ID # 12012016
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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