Cardiovascular DiseaseNCT01391416
Prevalence Of Hyperhomocysteinemia In Thai Chronic Kidney Disease (CKD) Patients
An observational study of Cardiovascular Disease and Hyperhomocysteinemia, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Hyperhomocysteinemia
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- CKD stages 3-4 from Thai SEEK Study
Who cannot join
- CKD stage 5
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiovascular Disease, Hyperhomocysteinemia
- Keywords
- Hyperhomocysteinemia, Chronic kidney disease
- Medical subject headings
- Cardiovascular Diseases, Hyperhomocysteinemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD stage 3-4 | CKD stage 3-4 from Thai SEEK study | |
| hyperhomocysteine group | CKD stage 3-4 from Thai SEEK study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Homocysteine
Level of homocysteinemia according to each CKD level
Measured: 3 months
Secondary outcomes (1)
Association of cardiovascular event to the level of homocysteine
Hugh level of homocysteine will have association with cardiovascular events or not
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
- Sponsor type
- Other government
- Investigators
- Thananda Trakarnvanich, M.D., Principal investigator, Renal Unit,Department of Medicine,Faculty of Medicine,Vajira Hospital,University of Bangkok Metropolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391416
- Sponsor's protocol ID
- VJR-0002
- Status last verified
- May 2010
- First submitted
- 8 Jul 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20037182
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Of Hyperhomocysteinemia In Thai CKD Patients And Relationship To Cardiovascular Events: Subgroup Analysis From Thai SEEK Study
- ClinicalTrials.gov ID
- NCT01391416
- Acronym / sponsor ID
- VJR-0002
- Conditions
- Cardiovascular Disease, Hyperhomocysteinemia
- Keywords
- Hyperhomocysteinemia, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Bangkok Metropolitan Administration Medical College and Vajira HospitalOther government
- Study start
- Jun 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD stage 3-4 | – | –CKD stage 3-4 from Thai SEEK study |
| hyperhomocysteine group | – | –CKD stage 3-4 from Thai SEEK study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- CKD stages 3-4 from Thai SEEK Study
Key exclusion criteria (1 listed)
- CKD stage 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Homocysteine
Time frame: 3 months
Level of homocysteinemia according to each CKD level
1 secondary outcome
Association of cardiovascular event to the level of homocysteine
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Background: PubMed 20037182Ingsathit 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.
- Research SubcommiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thananda Trakarnvanich, M.D. principal investigator
Renal Unit,Department of Medicine,Faculty of Medicine,Vajira Hospital,University of Bangkok Metropolis
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Hyperhomocysteinemia, run by Bangkok Metropolitan Administration Medical College and Vajira Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Homocysteine (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01391416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.