MedTrace Logo

Penicillamine Chelation for Children With Lead Poisoning

NCT00552630 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-03-26

No results posted yet for this study

Summary

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.

Conditions

  • Lead Poisoning
  • Vitamin D Deficiency

Interventions

DEVICE

d-penicillamine

d-penicillamine twice daily, 15 mg/kg/day, for 6 weeks

DRUG

placebo

placebo with same characteristics as drug

Sponsors & Collaborators

  • Bezoloven, Inc.

    collaborator INDUSTRY

  • FDA Office of Orphan Products Development

    lead FED

Principal Investigators

  • Michael W Shannon, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00552630 on ClinicalTrials.gov