The Combined Effect of 2,3-Dimercaptosuccinic Acid and Mu... | NCT00374894

Studies
The Combined Effect of 2,3-Dimercaptosuccinic Acid and Multi-Nutrients on Children in Lead Poisoning

NCT00374894

Sponsor

China Medical University, China

Status

Completed

Last Update Posted

Sep 12, 2006Estimated

Enrollment

500

Phase

Not provided

Conditions

Lead Poisoning

Interventions

2,3-dimercaptosuccinic acid

Countries

China

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

Apr 2004

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 2004

Primary Completion Date

Not provided

Completion Date

Aug 2004

First Submitted Date

Sep 11, 2006

First Submission Date that Met QC Criteria

Sep 11, 2006

First Posted Date

Sep 12, 2006Estimated

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

Sep 11, 2006

Last Update Posted Date

Sep 12, 2006Estimated

Description Module

Brief Summary

Lead poisoning remains a common disease among children despite successful public health efforts that reduced its prevalence.Our study was designed to test the hypothesis that lead-poisoning children (BLLs:100-440µg/L) who were given DMSA and multi-nutrients would have a greater fall than children of other groups at 12 weeks of follow-up.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Name	Type	Description	Arm Group Labels	Other Names
2,3-dimercaptosuccinic acid	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Initial BLLs 100-440µg/L
Age 3-6y
No more than two main residences
House cleaned (no lead contaminated)
Normal intake history and physical

Exclusion Criteria:

Chelation in the past 12 weeks
Concomitant Fe deficiency(ferritin<16ng/ml)
Hemoglobin<10.5g/dL
Medications affecting mineral metabolism

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Ya ping, professor	Department of Environmental and Occupational Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University		Shenyang	Liaoning	110001	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	CDC．Preventing lead poisoning in young children［R］. U.D.Dept of health and Human services 1991:1.

ID	Term
D000075322	Heavy Metal Poisoning
D011041	Poisoning
D064419	Chemically-Induced Disorders

ID	Term
D013386	Succinates
D003998	Dicarboxylic Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids