Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342849
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2006-06-19
Brief Title:
Treatment of Lead-Exposed Children Trial
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Lead-Exposed Children TLC Trial
Status:
COMPLETED
Status Verified Date:
2015-06-10
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:
The Treatment of Lead-Exposed Children TLC clinical trial compared the effect of lead chelation with succimer to placebo therapy TLC was a randomized double-blind placebo-controlled clinical trial with sites in Cincinnati and Columbus Ohio Philadelphia Pennsylvania Baltimore Maryland and Newark New Jersey The study was designed to test outcomes in IQ neuropsychological function behavior physical growth and blood pressure three years after initiation of treatment Enrollment was conducted between 1994 and 1997 with completion of the initial three-year follow-up in 2000
Detailed Description:
At TLC enrollment the children were between 12 and 33 months of age with baseline blood lead levels PbB between 20 and 44 microgdl Of 1854 referred children who were screened for eligibility 780 were randomized to the active drug oral succimer and placebo groups stratified by clinical center body surface area blood lead level and language spoken at home only the New Jersey Clinical Center enrolled Spanish-speaking participants Up to three 26-day courses of succimer or placebo therapy were administered depending on response to treatment in those who were given the active drug Eighty-nine percent of children had finished treatment by six months with all children finishing by 13 months after randomization Residential lead clean-up and nutritional supplementation with multivitamins and minerals were provided to all study children irrespective of treatment group Children were followed for three years with regular physical exams psychological and developmental testing and measurement of lead concentration in venous blood Treatment and follow up are closed for this trial it is open for scientific analysis and report writing only
Although succimer lowered blood lead levels much more effectively than placebo there was no difference between the two groups on any of the psychological tests at three years post randomization when most children were about five years old Follow up of TLC children continued into school age At age seven 647 of 780 subjects remained in the study Children were tested at age seven and again at seven and a half on standardized neuropsychological batteries that tap cognition behavior learning and memory attention and neuromotor skills While chelation therapy with succimer had lowered average blood lead levels for approximately six months it resulted in no benefit in cognitive behavioral and neuromotor endpoints when measured at school ages in these children These additional follow-up data confirm our previous finding that the TLC regimen of chelation therapy is not associated with neurodevelopmental benefits in children with blood lead levels between 20 and 44 microgdL
Although succimer lowered blood lead levels much more effectively than placebo there was no difference between the two groups on any of the psychological tests at three years post randomization when most children were about five years old Follow up of TLC children continued into school age At age seven 647 of 780 subjects remained in the study Children were tested at age seven and again at seven and a half on standardized neuropsychological batteries that tap cognition behavior learning and memory attention and neuromotor skills While chelation therapy with succimer had lowered average blood lead levels for approximately six months it resulted in no benefit in cognitive behavioral and neuromotor endpoints when measured at school ages in these children These additional follow-up data confirm our previous finding that the TLC regimen of chelation therapy is not associated with neurodevelopmental benefits in children with blood lead levels between 20 and 44 microgdL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH94-E-N037 | None | None | None |