A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis

Prematurity Clinical Trial

Official title:

Effect of Different Dosages Oral Vitamin D on Serum Interleukin-6 in Preterm Infants With Late-onset Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273843
• Other study ID #: MS 306
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2014
• Last updated: September 29, 2015
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Late-onset Sepsis
• Prematurity
• Sepsis
• Toxemia

Intervention

Drug:
• High-dose vitamin D 3
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 3
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

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit, Mansoura University Children Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Review. — View Citation

Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellöf 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	at trial entry, 7 days after daily vitamin D supplementation therapy and at 40 weeks postmenstrual age	No
Secondary	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	Yes
Secondary	Abdominal ultrasonography	Abdominal ultrasonography to detect any nephrocalcinosis will be done at 40 weeks postmenstrual age	40 weeks postmenstrual age	Yes
Secondary	Mortality	In-hospital mortality during NICU admission for an expected average of 5 weeks	Baseline	No
Secondary	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	No