Mercury Chelation to Treat Autism
Withdrawn before enrolling · Phase 2
Conditions studied: Autism, Asperger's Disorder, Child Development Disorders, Pervasive
In brief
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, although it has never been tested in a controlled study and there is no proof that it helps children with the disorder. Support for its use is based on single-case reports of benefits of chelation with DMSA. This study will help determine whether or not DMSA is useful for treating autism. Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33 pounds, who have detectable, but not toxic, levels of mercury or lead in the blood, and who have not previously received chelation therapy may be eligible for this study. Participants complete a medical history, behavioral and psychological assessment and physical examination. Blood, hair, urine and stool samples are collected for testing. Because DMSA can remove minerals the body needs, such as zinc and iron, as well as the toxic lead and mercury, participants take a daily multivitamin supplement starting 1 month before beginning chelation therapy and continuing for the duration of treatment. After 1 month of the supplementation regimen, the children are assigned to receive DMSA or placebo for 12 weeks, divided into six 2-week cycles. They take the assigned drug 3 times a day on days 1, 2 and 3 of each cycle and continue the multivitamin every day. The children are seen in the clinic immediately before and after the first, third and sixth cycles. At each checkup, the parent or guardian answers a set of questions about the child's autism symptoms, physical health and medication side effects. Blood, urine and stool samples are collected for laboratory testing. ...
Key facts
- Study ID
- NCT00376194
- Run by
- National Institute of Mental Health (NIMH)
- People needed
- 0
- Starts
- 2006-09-01
- Expected to finish
- 2007-03-01
- Last updated by the study team
- 2013-09-18
Who can join
Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- National Institute of Mental Health (NIMH), 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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