Lead PoisoningNCT00374894
The Combined Effect of 2,3-Dimercaptosuccinic Acid and Multi-Nutrients on Children in Lead Poisoning
An observational study of Lead Poisoning, run by China Medical University, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Lead Poisoning
- What is being tested?
- 2,3-dimercaptosuccinic acid
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Mar 2004to Aug 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Child
Who may be able to join
- Initial BLLs 100-440µg/L
- Age 3-6y
- No more than two main residences
- House cleaned (no lead contaminated)
- Normal intake history and physical
Who cannot join
- Chelation in the past 12 weeks
- Concomitant Fe deficiency(ferritin<16ng/ml)
- Hemoglobin<10.5g/dL
- Medications affecting mineral metabolism
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lead Poisoning
- Being tested
- 2,3-dimercaptosuccinic acid
- Keywords
- 2,3-dimercaptosuccinic acid, Blood Lead Levels, children, multi-nutrients
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2,3-dimercaptosuccinic acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startMar 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lead PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Investigators
- Jin Ya ping, professor, Study director, Department of Environmental and Occupational Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374894
- Sponsor's protocol ID
- 20032063 - 2001102049
- Status last verified
- Apr 2004
- First submitted
- 11 Sep 2006
- Last updated
- 12 Sep 2006
- Results posted
- No
Publications
CDC．Preventing lead poisoning in young children［R］. U.D.Dept of health and Human services 1991:1.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of 2,3-Dimercaptosuccinic Acid and Multi-Nutrients on Children in Lead Poisoning
- ClinicalTrials.gov ID
- NCT00374894
- Acronym / sponsor ID
- 20032063 - 2001102049
- Conditions
- Lead Poisoning
- Keywords
- 2,3-dimercaptosuccinic acid, Blood Lead Levels, children, multi-nutrients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Aug 2004
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- Initial BLLs 100-440µg/L
- Age 3-6y
- No more than two main residences
- House cleaned (no lead contaminated)
- Normal intake history and physical
Key exclusion criteria (4 listed)
- Chelation in the past 12 weeks
- Concomitant Fe deficiency(ferritin<16ng/ml)
- Hemoglobin<10.5g/dL
- Medications affecting mineral metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2,3-dimercaptosuccinic acid | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
- Results publicationCDC．Preventing lead poisoning in young children［R］. U.D.Dept of health and Human services 1991:1.
Related trials for Lead Poisoning
Not yet recruiting
A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
Lead Poisoning, Environmental Exposure
RecruitingObservational study
The α-gal Syndrome - Investigating Immune Reactions to Tick Bites
Alpha-Gal Syndrome
Not yet recruitingObservational study
Effectiveness of Environmental Measures to Eliminate the Risks of Lead Exposure in Infant Lead Poisoning
Poisoning
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Ya ping, professor study director
Department of Environmental and Occupational Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lead Poisoning, run by China Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.