Vitamin d Levels in Children With Bacterial Meningitis

• Conditions: Bacterial Meningitis

• Registration Number: NCT02467309
• Lead Sponsor: Gang Liu

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-03-18
• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted QC: 2015-06-05
• Last Update Submitted: 2015-06-05
• Study First Posted: 2015-06-10
• Last Update Posted: 2015-06-10
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vitamin d level change	change in serum vitamin d level from baseline to 28 days after initial hospitalization	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

Secondary Outcome Measures

Name	Time	Method
Clinical assessment of disease severity with Glasgow score	28 day	Disease severity will be assessed with Glasgow score in the twenty-eighth day of hospitalization
Clinical assessment of disease severity with cerebrospinal fluid examination	28 day	Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid
Assessment of complications	28 day	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
Clinical assessment of disease severity with pediatric critical illness score	28 day	Disease severity will be assessed with pediatric critical illness score in the twenty-eighth day of hospitalization