An interventional study of succimer in Lead Poisoning, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed. Open to participants aged 0 Years to 6 Years. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Treatment
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.
27 studies on the registry are indexed under Lead Poisoning; 2 are open to participants now.
This study's enrollment of 175 is close to the median of 175 across 11 interventional studies indexed under Lead Poisoning.
Browse Lead Poisoning studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No study locations are listed for this record.
This study is completed, as verified in Sep 1998. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Succimer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) →