NCT02273843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

1.9 years

First QC Date

October 20, 2014

Last Update Submit

September 29, 2015

Conditions

PrematurityLate-onset Sepsis

Keywords

Pretermlate-onset sepsisVitamin DDoseInterleukin-6Tumor necrosis factor-alpha

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Serum C-reactive protein (CRP)

    At trial entery and 7 days after daily vitamin D supplementation therapy

  • Serum 25(OH)D levels

    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

  • Abdominal ultrasonography

    40 weeks postmenstrual age

  • Mortality

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

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

Drug: High-dose vitamin D 3

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

Drug: Conventional-Dose Vitamin D 3

Interventions

High-dose vitamin D 3DRUG

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

Also known as: High-dose cholecalciferol
High-dose vitamin D
Conventional-Dose Vitamin D 3DRUG

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

Also known as: Conventional-dose cholecalciferol
Conventional-dose vitamin D

Eligibility Criteria

Age3 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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:
  • Temperature instability (hypothermia, hyperthermia);
  • Respiratory (grunting, intercoastal retraction, apnea, tachypnea, cyanosis);
  • Neurologic (hypotonia, lethargy, seizures);
  • Gastrointestinal (feeding intolerance, abdominal distension).

You may not qualify if:

  • Major congenital anomalies.
  • Chromosomal anomalies.
  • Known inborn error(s) of metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit, Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 23982028BACKGROUND

  • 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.

    PMID: 20511058BACKGROUND

  • 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.

    PMID: 24904851BACKGROUND

  • 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.

    PMID: 19881390BACKGROUND

  • 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.

    PMID: 23629620BACKGROUND

  • 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.

    PMID: 33305842DERIVED

  • 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.

    PMID: 30896608DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 24, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

EG(1)