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This is a randomized controlled trial (RCT) to evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis and to assess its influence on clinical outcomes of these infants.
Vitamin D has an important role in the regulation of both the innate and adaptive immune systems. There are very few studies of such roles in the neonatal population. It is potentially an attractive therapeutic agent for sepsis given its low cost and low risk of toxicity and side effects. There is no consensus regarding to the dose of vitamin D supplementation required for preterm infants given the paucity of evidence. AAP and ESPGHAN have recommended different dosages of vitamin D ranging from 400 IU to 1000 IU per day. The influence of different doses of vitamin D on immunological status and clinical outcomes of preterm infants with late-onset sepsis has not been evaluated before. This RCT will evaluate the influence of different doses of vitamin D3 (800 IU/d versus 400 IU/d), on serum levels of interleukin (IL)-6, TNF-alpha and C- reactive (CRP) in premature infants with clinical evidence of late-onset sepsis we will also evaluate their safety and influence on clinical outcomes of these infants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose vitamin D | Experimental | Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU |
|
| Conventional-dose vitamin D | Active Comparator | Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose vitamin D 3 | Drug | Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum interleukin-6 | Serum levels of interleukin-6 (IL-6) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy. IL-6 concentrations will be determined by Endogenous Interleukin-ELISA | At trial entry and 7 days after daily vitamin D supplementation therapy |
| Serum tumor necrosis-alpha | Serum levels of tumor necrosis-alpha (TNF-alpha) will be evaluated at enrollment and 7 days after daily vitamin D supplementation therapy | At trial entry and 7 days after daily vitamin D supplementation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Serum C-reactive protein (CRP) | Serum CRP will be evaluated at enrollment and 7 days | At trial entery and 7 days after daily vitamin D supplementation therapy |
| Serum 25(OH)D levels | Serum 25(OH)D levels will be measured by ELISA at trial entry, at day 7 and at 40 weeks postmenstrual age |
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Inclusion Criteria:
Preterm Infants (28-37 wk gestational age)
Late-onset sepsis defined as clinical signs suggestive of infection after 72 h of birth. Clinical sepsis will be defined as the presence of three or more of the following categories of clinical signs:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Mansoura University Children Hospital | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23982028 | Background | Moromizato T, Litonjua AA, Braun AB, Gibbons FK, Giovannucci E, Christopher KB. Association of low serum 25-hydroxyvitamin D levels and sepsis in the critically ill. Crit Care Med. 2014 Jan;42(1):97-107. doi: 10.1097/CCM.0b013e31829eb7af. | |
| 20511058 | Background | Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010. |
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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 |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| Conventional-Dose Vitamin D 3 | Drug | Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU |
|
|
| at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age |
| Serum calcium, phosphorus and urinary calcium | Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks | Participants will be followed for the duration of hospital stay, serum calcium, phosphorus and urinary calcium well be assessed every week for an expected average of 5 weeks |
| Abdominal ultrasonography | Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age | 40 weeks postmenstrual age |
| Mortality | In-hospital mortality during NICU admission for an expected average of 5 weeks | Baseline |
| Neonatal morbidities | Participants will be followed for the duration of hospital stay, for an expected average of 5 weeks and the incidence of neonatal morbidities e.g. NEC, retinopathy of prematurity, disseminated intravascular coagulopathy and renal dysfunction will be assessed | Participants will be followed for the duration of hospital stay, for an expected average of 4 weeks |
| 24904851 | Background | Kim SY. The pleiomorphic actions of vitamin D and its importance for children. Ann Pediatr Endocrinol Metab. 2013 Jun;18(2):45-54. doi: 10.6065/apem.2013.18.2.45. Epub 2013 Jun 30. |
| 19881390 | Background | Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0. |
| 23629620 | Background | Abrams SA; Committee on Nutrition. Calcium and vitamin d requirements of enterally fed preterm infants. Pediatrics. 2013 May;131(5):e1676-83. doi: 10.1542/peds.2013-0420. Epub 2013 Apr 29. |
| 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. |
| 30896608 | Derived | Abdel-Hady H, Yahia S, Megahed A, Mosbah A, Seif B, Nageh E, Bhattacharjee I, Aly H. Mediators in Preterm Infants With Late-onset Sepsis: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Apr;68(4):578-584. doi: 10.1097/MPG.0000000000002238. |
| D000091642 | Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |