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

Completed

• Conditions: Developmental Delays
• Interventions: Other: study group

• Registration Number: NCT02523989
• Lead Sponsor: Taipei Medical University

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 Timeline

• Study Start: 2010-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2015-08
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	study group	children confirmed to have developmental delays
control group	study group	children with typical development

Primary Outcome Measures

Name	Time	Method
heavy metal assessment	3 months	laboratory analysis

Secondary Outcome Measures

Name	Time	Method
quality of life	2 weeks	questionnaires analysis

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan