The Relationship Between Arsenic Methylation Capability and Blood Metals in Children With Developmental Delays

NCT ID: NCT02523989

Last Updated: 2015-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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.

Conditions

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Developmental Delays

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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study group

children confirmed to have developmental delays

study group

Intervention Type OTHER

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.

control group

children with typical development

study group

Intervention Type OTHER

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.

Interventions

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study group

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* children with developmental delays obtained written informed consent from parents


* 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

Control group:


* parents refused for participation of their children to the intervention failed to obtain the written informed consent from parents
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ru-Lan Hsieh

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Visiting staff

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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SKH-TMU-100-06

Identifier Type: -

Identifier Source: org_study_id

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