The Relationship Between Arsenic Methylation Capability a... | NCT02523989

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

NCT02523989

Sponsor

Taipei Medical University

Status

Completed

Last Update Posted

Aug 14, 2015Estimated

Enrollment

137Actual

Phase

Not provided

Conditions

Developmental Delays

Interventions

study group

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Aug 7, 2015

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2015

Last Update Posted Date

Aug 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		children confirmed to have developmental delays	Other: study group
control group		children with typical development	Other: study group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
heavy metal assessment	laboratory analysis	3 months

Secondary Outcomes

Measure	Description	Time Frame
quality of life	questionnaires analysis	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

children with developmental delays and children with normal development

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ru-Lan Hsieh, MD	Visiting staff	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shin Kong Wu Ho-Su Memorial Hospital		Taipei		111-01	Taiwan

Description

Blood and urine samples of participants were collected and urine used for the analysis of the arsenic species using high performance liquid chromatography linked hydride generator and atomic absorption spectrometry. Buffy coat were separated from plasma and extract DNA to analyze the genetic polymorphism 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.