Clinical trial · Interventional
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis
NCT02273843CI-TRIAL-00019256completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Late-onset Sepsis | — | UNRESOLVED | — |
| Prematurity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional-Dose Vitamin D 3 | Drug | — | UNRESOLVED |
| High-dose vitamin D 3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-dose vitamin D
- description
- 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
- interventionNames
- Drug: High-dose vitamin D 3
- type
- ACTIVE_COMPARATOR
- label
- Conventional-dose vitamin D
- description
- 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
- interventionNames
- Drug: Conventional-Dose Vitamin D 3
Primary outcomes (2)
- measure
- Serum interleukin-6
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Days
- Maximum age
- 28 Days
Show eligibility criteria text
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: 1. Temperature instability (hypothermia, hyperthermia); 2. Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis); 3. Neurologic (hypotonia, lethargy, seizures); 4. Gastrointestinal (feeding intolerance, abdominal distension). Exclusion Criteria: * Major congenital anomalies. * Chromosomal anomalies. * Known inborn error(s) of metabolism
References
Publications (7)
- BACKGROUNDMoromizato 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. PMID 23982028
- BACKGROUNDHewison 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. PMID 20511058
- BACKGROUNDKim 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. PMID 24904851
- BACKGROUNDAgostoni 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. PMID 19881390
- BACKGROUNDAbrams 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. PMID 23629620
- DERIVEDHuey 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