Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004838
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Randomized Study of Succimer Dimercaptosuccinic Acid on Growth of Lead-Poisoned Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
Compare growth of lead-poisoned children receiving succimer dimercaptosuccinic acid DMSA plus standard treatment to those receiving standard treatment only
Compare growth of lead-poisoned children receiving succimer dimercaptosuccinic acid DMSA plus standard treatment to those receiving standard treatment only
Detailed 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 mcgdL 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
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 mcgdL 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CH-OHIO-5F32ES05651 | None | None | None |
| CHRF-96-HS-066 | None | None | None |