Protocol Number: 06-M-0238

Title:

An Investigation of the Efficacy of Mercury Chelation as a Treatment for Autism Spectrum Disorder

Number:

06-M-0238

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, 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.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Pervasive Developmental Disorder

Alternative Therapy

Autism

Asperger's Disorder

Clinical Trial

Recruitment Keyword(s):

Autism

Autism Spectrum Disorder

ASD

Pervasive Developmental Disorder

Asperger Disorder

Condition(s):

Autism

Asperger's Disorder

Child Development Disorders, Pervasive

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: DMSA

Supporting Site:

NIMH

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Aposhian HV, Aposhian MM. meso-2,3-Dimercaptosuccinic acid: chemical, pharmacological and toxicological properties of an orally effective metal chelating agent. Annu Rev Pharmacol Toxicol. 1990;30:279-306. Review.

Bernard S, Enayati A, Redwood L, Roger H, Binstock T. Autism: a novel form of mercury poisoning. Med Hypotheses. 2001 Apr;56(4):462-71. Review.

Chisolm JJ Jr. Safety and efficacy of meso-2,3-dimercaptosuccinic acid (DMSA) in children with elevated blood lead concentrations. J Toxicol Clin Toxicol. 2000;38(4):365-75.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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