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Clinical Trials/NCT02523989
NCT02523989CompletedNot Applicable

The Relationship Between Genetic Polymorphism of Arsenic Methylation Enzymes, Arsenic Methylation Capability and Blood Metals, and Developmental Delays in Preschool Children

Taipei Medical University1 site in 1 country137 target enrollmentStarted: March 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
137
Locations
1
Primary Endpoint
heavy metal assessment

Study Overview

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.

Detailed Description

The investigators recruited children with developmental delays and children with normal development from Shin-Kong Ho-Su Memorial Hospital as controls. Information obtained from the interview included socioeconomic and basic demographic characteristics as well as children function, health condition, and quality of life. On the other hand, blood and urine samples of the participants were collected for the analysis 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. The relationship between arsenic methylation and blood metals in children with developmental delays and its correlation with health related quality of were analyzed.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
2 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • children with developmental delays obtained written informed consent from parents

Exclusion Criteria

  • parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents
  • Control group:
  • Inclusion Criteria:
  • children with normal development obtained written informed consent from parents
  • Exclusion Criteria:
  • parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents

Outcomes

Primary Outcomes

heavy metal assessment

Time Frame: 3 months

laboratory analysis

Secondary Outcomes

  • quality of life(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ru-Lan Hsieh

Associate Professor

Taipei Medical University

Study Sites (1)

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