Vitamin d Levels in Children With Bacterial Meningitis
Association of Serum 25-hydroxyvitamin D Levels and Outcomes in Children With Bacterial Meningitis
1 other identifier
observational
50
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether deficiency of Vitamin D has association with outcomes of children with bacterial meningitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 10, 2015
May 1, 2015
1 year
March 18, 2015
June 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Clinical assessment of disease severity with Glasgow score
1 day
Clinical assessment of disease severity with Glasgow score
7 day
Clinical assessment of disease severity with Glasgow score
28 day
Clinical assessment of disease severity with pediatric critical illness score
1 day
Clinical assessment of disease severity with pediatric critical illness score
7 day
- +7 more secondary outcomes
Eligibility Criteria
patients who are diagnosed with bacterial meningitis in infectious diseases department of Beijing Children's Hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gang Liulead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- director, chief physician, professor
Study Record Dates
First Submitted
March 18, 2015
First Posted
June 10, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 10, 2015
Record last verified: 2015-05