Penicillamine Chelation for Children With Lead Poisoning
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|ClinicalTrials.gov Identifier: NCT00552630|
Recruitment Status : Withdrawn
First Posted : November 2, 2007
Last Update Posted : March 26, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lead Poisoning Vitamin D Deficiency||Device: d-penicillamine Drug: placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2/3 Trial of d-Penicillamine Chelation in Lead-Poisoned Children|
|Study Start Date :||September 2007|
This group will receive d-penicillamine for 6 weeks
d-penicillamine twice daily, 15 mg/kg/day, for 6 weeks
Placebo Comparator: 2
This group will receive placebo for 6 weeks
placebo with same characteristics as drug
- • 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. [ Time Frame: 6 weeks ]
- To determine whether d-penicillamine produces a sustained reduction in blood lead level and improves the physiologic disturbances that can be measured in children with blood lead levels in this range. [ Time Frame: 10 weeks ]
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): NCT00552630
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Study Director:||Michael W Shannon, MD||Boston Children’s Hospital|