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

Developmental Delays Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523989
• Other study ID #: SKH-TMU-100-06
• Status: Completed
• Phase: N/A
• First received: August 7, 2015
• Last updated: August 13, 2015
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2015
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Developmental Delays

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heavy metal assessment	laboratory analysis	3 months	No
Secondary	quality of life	questionnaires analysis	2 weeks	No