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Home > "R" Clinical Trials Conditions > Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children  Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
For Condition: Lead Poisoning
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Children's Hospital Columbus
Synopsis: OBJECTIVES: Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: /6 Years
Genders: Both
Protocol Entry Criteria: 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)
Total Enrollment: 175
Location and Contact Information:
Overall Study Official:
MarcelCasavant, Study Chair, Children's Hospital Columbus
Additional Information:
Study ID Numbers: 199/13576; CHRF-96-HS-066,CH-OHIO-5F32ES05651
Study Start Date: September 1997
Record last reviewed: September 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004838
Other Lead Poisoning Studies:
1. Lead, Endocrine Disruption and Reproductive Outcomes
2. Bone Lead Levels and College Achievement Scores
3. Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
4. Does Lead Burden alter Neuropsychological Development?
5. Exposure, Dose, Body Burden and Health Effects of Lead
Related Studies:
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Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
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