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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | Subjects in this group receive 400 IU vitamin D daily for 4 weeks. |
|
| High dose | Experimental | Subjects in this group receive 800 IU vitamin D daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Oral vitamin D |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lamiaa Mohsen, MD | Cairo University Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28779655 | Result | 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. | |
| 15209957 |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 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. |
| 33305842 | Derived | 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. |
| 31335838 | 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. |
| D000091642 | Urogenital Diseases |