Vitamin d Levels in Children With Bacterial Meningitis

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

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

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who are diagnosed with bacterial meningitis in infectious diseases department of Beijing Children's Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of disease severity with Glasgow score	Disease severity will be assessed with Glasgow score in the first day of hospitalization	1 day
Clinical assessment of disease severity with Glasgow score	Disease severity will be assessed with Glasgow score in the seventh day of hospitalization	7 day
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
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
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
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
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
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
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
Assessment of complications	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.	1 day
Assessment of complications	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.	7 day
Assessment of complications	Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.	28 day

Collaborators and Investigators

• Sponsor: Gang Liu

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Estimate): June 10, 2015
• Last Update Submitted That Met QC Criteria: June 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Meningitis; Meningitis, Bacterial
• Other Study ID Numbers: 20150203