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| ID | Type | Description | Link |
|---|---|---|---|
| CHRF-96-HS-066 | |||
| CH-OHIO-5F32ES05651 |
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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
OBJECTIVES:
Compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; DMSA) plus standard treatment to those receiving standard treatment only.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| succimer | Drug |
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)
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| Name | Affiliation | Role |
|---|---|---|
| Marcel J. Casavant | Nationwide Children's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9690266 | Background | The Treatment of Lead-exposed Children (TLC) trial: design and recruitment for a study of the effect of oral chelation on growth and development in toddlers. Paediatr Perinat Epidemiol. 1998 Jul;12(3):313-33. doi: 10.1046/j.1365-3016.1998.00122.x. |
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| ID | Term |
|---|---|
| D007855 | Lead Poisoning |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D000075322 | Heavy Metal Poisoning |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D004113 | Succimer |
| ID | Term |
|---|---|
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |