Status:
WITHDRAWN
Mercury Chelation to Treat Autism
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Autism
Asperger's Disorder
Eligibility:
All Genders
4-10 years
Phase:
PHASE2
Brief Summary
This study will examine whether DMSA, an oral chelating agent that removes mercury and other metals from the body, is beneficial for children with autism. DMSA is commonly used to treat autism, althou...
Detailed Description
Chelation of metals is widely used in the community to treat individuals with Autism Spectrum Disorder (ASD), with some surveys estimating that 1 in 12 children with autism have undergone chelation. T...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects may be included in the study only if they meet all of the following criteria:
- Male or female subjects, four to ten years of age.
- Meets research criteria for ASD (specifically, autism, Asperger Disorder, or Pervasive Developmental Disorder - Not Otherwise Specified).
- Detectable (greater than 0.1 microgram per deciliter) levels of blood lead and/or blood mercury.
- Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study and must provide written consent to study protocol.
- EXCLUSION CRITERIA:
- History of allergic reaction to sulfur or thiol-containing substances
- History of previous chelation therapy for autism
- History of uncontrolled epilepsy
- Weight less than 15 kg at screening
- Presence of a chronic medical condition that might interfere with study participation in which study participation would be contraindicated or in which there may be clinically significant abnormal baseline laboratory results.
- Level of lead above 10 microgram per d, or level of mercury over 44 microgram per deciliter (toxic levels that require intervention with chelation and preclude placebo assignment) or other evidence of heavy metal toxicity.
- Recent (less than two months prior to study entry) initiation of behavior therapy
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00376194
Start Date
September 1 2006
End Date
March 1 2007
Last Update
September 18 2013
Active Locations (1)
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1
National Institute of Mental Health (NIMH), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892