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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Nationwide Children's Hospital |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004838 |
OBJECTIVES:
Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
Condition | Intervention |
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Lead Poisoning |
Drug: succimer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 175 |
Study Start Date: | September 1997 |
Estimated Study Completion Date: | July 1998 |
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.
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Asymptomatic children with confirmed venous blood lead of at least 20 mcg/dL and less than 45 mcg/dL Children with blood lead of 45 mcg/dL or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --Patient Characteristics-- Other: No contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)
Study ID Numbers: | 199/13576, CHRF-96-HS-066, CH-OHIO-5F32ES05651 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004838 History of Changes |
Health Authority: | United States: Federal Government |
environmental/toxic disorders lead poisoning rare disease |
Succimer Rare Diseases Lead Poisoning |
Poisoning Disorders of Environmental Origin Chelating Agents |
Succimer Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Poisoning Lead Poisoning |
Disorders of Environmental Origin Chelating Agents Protective Agents Pharmacologic Actions Antidotes |