Treatment of Lead-Exposed Children Trial
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|ClinicalTrials.gov Identifier: NCT00342849|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lead Exposure||Drug: Succimer Drug: Placebo||Phase 3|
At TLC enrollment, the children were between 12 and 33 months of age with baseline blood lead levels (PbB) between 20 and 44 microg/dl. Of 1,854 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 microg/dL.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||780 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Treatment of Lead-Exposed Children (TLC) Trial|
|Study Start Date :||July 15, 1994|
|Actual Primary Completion Date :||August 29, 2007|
|Actual Study Completion Date :||June 10, 2015|
Scuccimer Treatment Group
Succimer (2,3-meso-dimercaptosuccinic acid) is an orally active dithiol compound that is a relatively specific chelating agent for heavy metals, especially lead, arsenic and mercury. The drug undergoes limited absorption in the gastrointestinal tract and then is rapidly metabolized to mixed disulfides which are eliminated in the urine. Blood levels decline slowly with an apparent elimination half-life of about 48 hours in adults.
Placebo Comparator: 2
In order to provide placebo with an odor comparable to that of succimer, the Drug Distribution Center will place a small canister containing 200 mg of active drug into each bottle of placebo drug. A canister containing 200 mg of placebo will be placed inside each bottle of succimer so that all bottles will appear the same.
- Efficacy [ Time Frame: Annually ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342849
|United States, Maryland|
|Kennedy Krieger Institute|
|Baltimore, Maryland, United States, 21205|
|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey|
|Newark, New Jersey, United States, 07103|
|United States, Ohio|
|Childrens Hospital, Columbus|
|Columbus, Ohio, United States, 43205-2696|
|United States, Pennsylvania|
|Childrens Hospital, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Walter Rogan, M.D.||National Institute of Environmental Health Sciences (NIEHS)|