The Relationship Between Arsenic Methylation Capability and Blood Metals in Children With Developmental Delays
The Relationship Between Genetic Polymorphism of Arsenic Methylation Enzymes, Arsenic Methylation Capability and Blood Metals, and Developmental Delays in Preschool Children
1 other identifier
observational
137
1 country
1
Brief Summary
The purpose of this study is to explore the relationship between arsenic methylation and blood metals in children with developmental delays and its correlation with health related quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedAugust 14, 2015
August 1, 2015
1.3 years
August 7, 2015
August 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
heavy metal assessment
laboratory analysis
3 months
Secondary Outcomes (1)
quality of life
2 weeks
Study Arms (2)
study group
children confirmed to have developmental delays
control group
children with typical development
Interventions
Explore the relationship of heavy metals and health related quality of life, including the relationship between the developmental delays and polymorphism of arsenic methylation enzymes, arsenic methylation capability and blood metals. Identify the interaction of children function, health condition, and quality of life and arsenic methylation and blood metals in children with developmental delays.
Eligibility Criteria
children with developmental delays and children with normal development
You may qualify if:
- children with developmental delays obtained written informed consent from parents
You may not qualify if:
- parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents
- Control group:
- children with normal development obtained written informed consent from parents
- parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01, Taiwan
Biospecimen
Blood and urine samples of participants were collected and urine used for the analysis of the arsenic species using high performance liquid chromatography linked hydride generator and atomic absorption spectrometry. Buffy coat were separated from plasma and extract DNA to analyze the genetic polymorphism of arsenic methylation related enzymes using polymerase chain reaction and restriction fragment length polymorphism. 2 ml blood were digested for the determination of mercury, lead and arsenic.
Study Officials
- PRINCIPAL INVESTIGATOR
Ru-Lan Hsieh, MD
Visiting staff
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 14, 2015
Study Start
March 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
August 14, 2015
Record last verified: 2015-08