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Completed

NCT Number: NCT02523989

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

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.

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Key information

Conditions

Developmental Delays

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Study group:

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

Treatment and study plan

Study Group

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.

Primary outcomes

  1. heavy metal assessment

    Time frame: 3 months

    laboratory analysis

Secondary outcomes

  1. quality of life

    Time frame: 2 weeks

    questionnaires analysis

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 14, 2015
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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