Vitamin d Levels in Children With Bacterial Meningitis

June 5, 2015 updated by: Gang Liu

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
vitamin d level change
Time Frame: 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
change in serum vitamin d level from baseline to 28 days after initial hospitalization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical assessment of disease severity with Glasgow score
Time Frame: 1 day
Disease severity will be assessed with Glasgow score in the first day of hospitalization
1 day
Clinical assessment of disease severity with Glasgow score
Time Frame: 7 day
Disease severity will be assessed with Glasgow score in the seventh day of hospitalization
7 day
Clinical assessment of disease severity with Glasgow score
Time Frame: 28 day
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
Time Frame: 1 day
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
Time Frame: 7 day
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
Time Frame: 28 day
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
Time Frame: 1 day
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
Time Frame: 7 day
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
Time Frame: 28 day
Cerebrospinal fluid examination including white blood cell count, protein concentration and glucose concentration in cerebrospinal fluid
28 day
Assessment of complications
Time Frame: 1 day
Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
1 day
Assessment of complications
Time Frame: 7 day
Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
7 day
Assessment of complications
Time Frame: 28 day
Assessment of complications include whether patients have complications, which kind of complication patients suffered, and whether needing surgical therapy.
28 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gang Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20150203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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