Vitamin d Levels in Children With Bacterial Meningitis

Bacterial Meningitis Clinical Trial

Official title:

Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02467309
• Other study ID #: 20150203
• Status: Not yet recruiting
• Phase: N/A
• First received: March 18, 2015
• Last updated: June 5, 2015
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2015
• Source: Beijing Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.

Description:

Vitamin D deficiency has been proved in serious diseases patients, including patients in shock, however, few study have been done about association between deficiency of Vitamin D and outcomes of children with bacterial meningitis.

in our study, we will observe incidence of complication and severity of complication between patients who have different Vitamin D status.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following:

A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl)

• Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis

Exclusion Criteria:

• Congenital immunodeficiency patients

• HIV patients

• Patients with corticosteroid treatment for long time

• Patients with disorders in adrenal gland and pituitary gland and hypothalamus

• Patients with tuberculosis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Meningitis
• Meningitis
• Meningitis, Bacterial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gang Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin d level change	Serum vitamin d level will be detected in the first day of hospitalization and twenty-eighth day of hospitalization, no vitamin d supplementation during this time	change in serum vitamin d level from baseline to 28 days after initial hospitalization	No
Secondary	Clinical assessment of disease severity with Glasgow score	Disease severity will be assessed with Glasgow score in the first day of hospitalization	1 day	No
Secondary	Clinical assessment of disease severity with Glasgow score	Disease severity will be assessed with Glasgow score in the seventh day of hospitalization	7 day	No
Secondary	Clinical assessment of disease severity with Glasgow score	Disease severity will be assessed with Glasgow score in the twenty-eighth day of hospitalization	28 day	No
Secondary	Clinical assessment of disease severity with pediatric critical illness score	Disease severity will be assessed with pediatric critical illness score in the first day of hospitalization	1 day	No
Secondary	Clinical assessment of disease severity with pediatric critical illness score	Disease severity will be assessed with pediatric critical illness score in the seventh day of hospitalization	7 day	No
Secondary	Clinical assessment of disease severity with pediatric critical illness score	Disease severity will be assessed with pediatric critical illness score in the twenty-eighth day of hospitalization	28 day	No
Secondary	Clinical assessment of disease severity with cerebrospinal fluid examination	Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid	1 day	No
Secondary	Clinical assessment of disease severity with cerebrospinal fluid examination	Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid	7 day	No
Secondary	Clinical assessment of disease severity with cerebrospinal fluid examination	Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid	28 day	No
Secondary	Assessment of complications	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.	1 day	No
Secondary	Assessment of complications	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.	7 day	No
Secondary	Assessment of complications	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.	28 day	No