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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01391416
Other study ID # VJR-0002
Secondary ID
Status Completed
Phase N/A
First received July 8, 2011
Last updated July 11, 2011
Start date June 2010
Est. completion date January 2011

Study information

Verified date May 2010
Source Bangkok Metropolitan Administration Medical College and Vajira Hospital
Contact n/a
Is FDA regulated No
Health authority Thailand:Ethics Committee for Researches Involving Human Subjects ,The Bangkok Metropolitan Administration
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date January 2011
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- CKD stages 3-4 from Thai SEEK Study

Exclusion Criteria:

- CKD stage 5

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

References & Publications (1)

Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Level of Homocysteine Level of homocysteinemia according to each CKD level 3 months Yes
Secondary Association of cardiovascular event to the level of homocysteine Hugh level of homocysteine will have association with cardiovascular events or not 3 months Yes
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