Clinical trial NCT02273843: A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
Official title: Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prematurity
Late-onset Sepsis
Keywords: Preterm
late-onset sepsis
Vitamin D
Dose
Interleukin-6
Tumor necrosis factor-alpha
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Serum interleukin-6
timeFrame: At trial entry and 7 days after daily vitamin D supplementation therapy
measure: Serum tumor necrosis-alpha
timeFrame: At trial entry and 7 days after daily vitamin D supplementation therapy
Secondary outcomes:
measure: Serum C-reactive protein (CRP)
timeFrame: At trial entery and 7 days after daily vitamin D supplementation therapy
measure: Serum 25(OH)D levels
timeFrame: at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age
measure: Serum calcium, phosphorus and urinary calcium
timeFrame: 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
measure: Abdominal ultrasonography
timeFrame: 40 weeks postmenstrual age
measure: Mortality
timeFrame: Baseline
measure: Neonatal morbidities
timeFrame: Participants will be followed for the duration of hospital stay, for an expected average of 4 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Neonatal Intensive Care Unit, Mansoura University Children Hospital
state: Dakahlia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.