Vitamin d Levels in Children With Bacterial Meningitis

Sponsor
Gang Liu (Other)
Overall Status
Unknown status
CT.gov ID
NCT02467309
Collaborator
(none)
50
13

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis
    Study Start Date :
    May 1, 2015
    Anticipated Primary Completion Date :
    May 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Clinical assessment of disease severity with Glasgow score [1 day]

      Disease severity will be assessed with Glasgow score in the first day of hospitalization

    2. Clinical assessment of disease severity with Glasgow score [7 day]

      Disease severity will be assessed with Glasgow score in the seventh day of hospitalization

    3. 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

    4. Clinical assessment of disease severity with pediatric critical illness score [1 day]

      Disease severity will be assessed with pediatric critical illness score in the first day of hospitalization

    5. Clinical assessment of disease severity with pediatric critical illness score [7 day]

      Disease severity will be assessed with pediatric critical illness score in the seventh day of hospitalization

    6. 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

    7. Clinical assessment of disease severity with cerebrospinal fluid examination [1 day]

      Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid

    8. Clinical assessment of disease severity with cerebrospinal fluid examination [7 day]

      Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid

    9. 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

    10. Assessment of complications [1 day]

      Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.

    11. Assessment of complications [7 day]

      Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.

    12. Assessment of complications [28 day]

      Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    1. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Gang Liu

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gang Liu, director, chief physician, professor, Beijing Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02467309
    Other Study ID Numbers:
    • 20150203
    First Posted:
    Jun 10, 2015
    Last Update Posted:
    Jun 10, 2015
    Last Verified:
    May 1, 2015
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2015