Penicillamine Chelation for Children With Lead Poisoning
Withdrawn before enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Lead Poisoning, Vitamin D Deficiency
In brief
Childhood Lead Poisoning is a widespread disease that has few effective treatments. The specific aims of this proposed clinical trial are threefold: * To determine whether a six-week course of a newly formulated d-penicillamine suspension will effectively reduce blood lead level in children aged 6 months to 16 years with blood lead levels of 15-25 μg/dL. * To determine whether d-penicillamine chelation produces a sustained reduction in blood lead level in comparison with succimer and other lead chelators which always produce a significant post-treatment "rebound". * To determine whether chelation with d-penicillamine improves the physiologic disturbances that can be measured in children with blood lead levels in this range.
Key facts
- Study ID
- NCT00552630
- Run by
- FDA Office of Orphan Products Development
- People needed
- 0
- Starts
- 2007-09-01
- Last updated by the study team
- 2015-03-26
Who can join
Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Potential subjects will be children 6 months to 16 years of age with blood lead level 15-25 mcg/dL on two separate occasions separated by at least two weeks
You may not qualify if…
- allergic to d-penicillamine
- renal insufficiency
- taking immunosuppressive agents
- pre-existing idiopathic thrombocytopenia (platelet count < 100,000/mm3) or leukopenia (WBC count < 5,000/mm3 or polymorphonuclear leukocyte count < 1000/mm3)
- blood lead level on the day of the initial clinic visit is below15 μg/dL or above 25 μg/dL
- blood lead level at the two-week follow up visit rises above 25 mcg/dL or falls below 15 mcg/dL
- currently undergoing chelation or have had chelation therapy in the previous two months
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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