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Methylation Biosignature in Childhood Chronic Kidney Disease

Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02022046
Acronym
childhoodCKD
Enrollment
69
Registered
2013-12-27
Start date
2014-04-30
Completion date
2016-12-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Chronic Kidney Disease

Keywords

chronic kidney disease, cardiovascular disease, nitric oxide, homocysteine, asymmetric dimethylarginine, methylation

Brief summary

Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker. In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway. The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.

Interventions

OTHERMethylation biosignature

Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* chronic kidney disease stage 1-4 * Volunteer

Exclusion criteria

* pregnancy * renal transplant * congenital heart disease * not able to be adherent/complaint with study procedure * not volunteer

Design outcomes

Primary

MeasureTime frameDescription
change from baseline level of asymmetric dimethylarginine (ADMA) at 24 monthsfrom the time of enrollment, every 6 months, up to 24 monthsat the time of enrollment, 6 months, 12 months, 18 months, and 24 months

Secondary

MeasureTime frameDescription
change from the baseline level of hyperhomocysteinemia (Hcy) at 24 monthsfrom the time of enrollment, every 6 months, up to 24 monthsat the time of enrollment, 6 months, 12 months, 18 months, 24 months
change from the baseline health-related quality of life at 24 monthsfrom the time of enrollment, every 6 months, up to 24 monthsEQ-5D-Y instrument will be employed at the time of enrollment, 6 months, 12 months, 18 months, 24 months
change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 monthsfrom the time of enrollment, every 6 months, up to 24 monthsat the time of enrollment, 6 months, 12 months, 18 months, 24 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026