- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391416
Prevalence Of Hyperhomocysteinemia In Thai Chronic Kidney Disease (CKD) Patients
July 11, 2011 updated by: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Prevalence Of Hyperhomocysteinemia In Thai CKD Patients And Relationship To Cardiovascular Events: Subgroup Analysis From Thai SEEK Study
It is well recognized that patients with chronic kidney disease (CKD) have an increased risk for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of future CVD events.
Hyperhomocysteinemia has been reported to bo of high prevalence in patients with CKD.
The investigators aim to study the prevalence of hyperhomocysteinemia in Thai CKD patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK) study database and their relationship to CVD.
Study Overview
Status
Completed
Conditions
Detailed Description
Ninety eight subjects were sampling from Thai SEEK study database Traditional Traditional risk factors of CVD such as total cholesterol, triglyceride, age, sex, history of smoking and blood pressure levels were examined and recorded.
Stored sera of these subjects were analyzed for the total homocysteine (tHcy) level.
Analysis of variance was used to evaluate the different of mean tHcy among groups
Study Type
Observational
Enrollment (Actual)
98
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
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Ninety eight subjects from CKD stages 3-4 were randomly sampling from Thai- SEEK study database.
Thai-SEEK study is a community-based cross-sectional survey that was conducted between August 2007-june 2008 in four regions of Thailand (i.e Northern, Northeastern, Central and Southern) and Bangkok (Metropolitan).
Description
Inclusion Criteria:
- CKD stages 3-4 from Thai SEEK Study
Exclusion Criteria:
- CKD stage 5
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
Cohorts and Interventions
Group / Cohort |
---|
CKD stage 3-4
CKD stage 3-4 from Thai SEEK study
|
hyperhomocysteine group
CKD stage 3-4 from Thai SEEK study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of Homocysteine
Time Frame: 3 months
|
Level of homocysteinemia according to each CKD level
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association of cardiovascular event to the level of homocysteine
Time Frame: 3 months
|
Hugh level of homocysteine will have association with cardiovascular events or not
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thananda Trakarnvanich, M.D., Renal Unit,Department of Medicine,Faculty of Medicine,Vajira Hospital,University of Bangkok Metropolis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
June 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
July 8, 2011
First Submitted That Met QC Criteria
July 11, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Estimate)
July 12, 2011
Last Update Submitted That Met QC Criteria
July 11, 2011
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VJR-0002
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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