Different Doses of Vitamin D and T Regulatory Cells in Preterm Infants
NCT ID: NCT03793309
Last Updated: 2019-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2017-01-09
2017-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose
Subjects in this group receive 400 IU vitamin D daily for 4 weeks.
Vitamin D
Oral vitamin D
High dose
Subjects in this group receive 800 IU vitamin D daily for 4 weeks.
Vitamin D
Oral vitamin D
Interventions
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Vitamin D
Oral vitamin D
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Bowel perforation
* Chromosomal anomalies
* Inborn errors of metabolism
* Major congenital anomalies
28 Days
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Lamiaa Mohsen
professor of Pediatrics
Principal Investigators
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Lamiaa Mohsen, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University Children's Hospital
References
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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.
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.
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.
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.
Other Identifiers
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12012016
Identifier Type: -
Identifier Source: org_study_id
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