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

NCT03793309 | Completed Phase 1

• 1 other identifier: 12012016
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prematurity; Immune Defect

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Low dose

EXPERIMENTAL

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

Drug: Vitamin D

High dose

EXPERIMENTAL

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

Drug: Vitamin D

Interventions

Vitamin D DRUG

Oral vitamin D

Also known as: Oral vitamin D

High dose; Low dose

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with gestational age 28-33 weeks

You may not qualify if:

• Necrotizing enterocolitis
• Bowel perforation
• Chromosomal anomalies
• Inborn errors of metabolism
• Major congenital anomalies

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• 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.

  PMID: 28779655 RESULT

• 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.

  PMID: 15209957 RESULT

• 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.

  PMID: 33305842 DERIVED

• 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.

  PMID: 31335838 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lamiaa Mohsen, MD

  Cairo University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Pediatrics

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 4, 2019
• Study Start: January 9, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share