NCT01391416

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

July 12, 2011

Status Verified

May 1, 2010

Enrollment Period

5 months

First QC Date

July 8, 2011

Last Update Submit

July 11, 2011

Conditions

Keywords

HyperhomocysteinemiaChronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • Level of Homocysteine

    Level of homocysteinemia according to each CKD level

    3 months

Secondary Outcomes (1)

  • Association of cardiovascular event to the level of homocysteine

    3 months

Study Arms (2)

CKD stage 3-4

CKD stage 3-4 from Thai SEEK study

hyperhomocysteine group

CKD stage 3-4 from Thai SEEK study

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • CKD stages 3-4 from Thai SEEK Study

You may not qualify if:

  • CKD stage 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 20037182BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Cardiovascular DiseasesHyperhomocysteinemiaRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thananda Trakarnvanich, M.D.

    Renal Unit,Department of Medicine,Faculty of Medicine,Vajira Hospital,University of Bangkok Metropolis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 12, 2011

Study Start

June 1, 2010

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

July 12, 2011

Record last verified: 2010-05