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Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
This study has been completed.
Study NCT00004838   Information provided by Office of Rare Diseases (ORD)
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
September 1997
 
 
 
Complete list of historical versions of study NCT00004838 on ClinicalTrials.gov Archive Site
 
 
 
Randomized Study of Succimer (Dimercaptosuccinic Acid) on Growth of Lead-Poisoned Children
 

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.

 
Interventional
Treatment, Randomized
Lead Poisoning
Drug: succimer
 
[No authors listed] 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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
175
July 1998
 

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)

Both
up to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004838
 
199/13576, CHRF-96-HS-066, CH-OHIO-5F32ES05651
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nationwide Children's Hospital
Study Chair: Marcel J. Casavant Nationwide Children's Hospital
Office of Rare Diseases (ORD)
September 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP