Clinical Trials Logo

Clinical Trial Summary

OBJECTIVES:

Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.


Clinical Trial Description

PROTOCOL OUTLINE: This is randomized study. Patients are randomized to receive succimer in addition to standard treatment (arm I) or standard treatment only (arm II).

Succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. Patients may receive up to 3 courses.

Standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels.

If blood lead level rises above 45 mcg/dL, patient receives succimer regardless of treatment arm originally assigned.

Patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter. ;


Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004838
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase N/A
Start date September 1997
Completion date July 1998

See also
  Status Clinical Trial Phase
Completed NCT01573013 - Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children N/A
Withdrawn NCT00552630 - Penicillamine Chelation for Children With Lead Poisoning Phase 2/Phase 3
Completed NCT00014885 - Bone Lead Levels and College Achievement Scores N/A
Enrolling by invitation NCT05265572 - Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump N/A
Completed NCT01739166 - QI Study of a Practice Facilitator's Impact in Working With Clinics on Improving Dental, Lead & Obesity Measures for Children N/A
Completed NCT00285610 - Early Exposure to Lead and Adult Antisocial Outcomes N/A
Completed NCT00011674 - Early Exposure to Lead and Adolescent Development N/A
Completed NCT00374894 - The Combined Effect of 2,3-Dimercaptosuccinic Acid and Multi-Nutrients on Children in Lead Poisoning N/A
Completed NCT00011661 - Social Network Based Intervention to Reduce Lead Exposure Among Native American Children N/A
Recruiting NCT03256383 - Plan for Testing Fingerstick Bloods on Magellan Systems N/A
Recruiting NCT05950386 - Effects of Lead Exposure on Ferroptosis Pathway
Completed NCT02346188 - Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead N/A
Completed NCT00013858 - Environmental Contaminants and Infant Development N/A
Completed NCT00013819 - Exposure, Dose, Body Burden and Health Effects of Lead N/A
Active, not recruiting NCT05744752 - Effects of Allium Sativum and Moringa Oleifera Extract on Dental Enamel N/A
Completed NCT00012480 - Effect of Environmental Exposures on the Egg Fertilizing Ability of Human Sperm N/A
Completed NCT00011726 - Lead Mobilization & Bone Turnover in Pregnancy/Lactation N/A
Completed NCT00023101 - Lead, Endocrine Disruption and Reproductive Outcomes N/A
Terminated NCT04498845 - RECLEAN Pilot Study N/A
Recruiting NCT00926406 - Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis N/A