Mercury Chelation to Treat Autism

NCT ID: NCT00376194

Last Updated: 2013-09-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-03-31

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, 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.

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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. This widespread use reflects the hypothesis that many cases of ASD are caused by exposure to thimerosal, an ethylmercury-based compound used previously in the US as a vaccine preservative for routine childhood immunizations. The prevalent use of chelation therapy stands in stark contrast with the lack of scientific or clinical evidence of efficacy, and creates a public health imperative for empiric data. Thus we propose a controlled trial of the effects of chelation on the core behavioral symptoms and overall functioning of children with ASD. The present investigation is a double-blind, randomized placebo-controlled study of the oral chelating agent meso-2,3-dimercaptosuccinic acid (DMSA; succimer) among 120 children, ages four to ten years, who meet criteria for ASD. Pre- and post-treatment behavioral ratings will be used to evaluate the efficacy of chelation. In addition, children will undergo comprehensive medical history, physical examination and laboratory analyses.

Our objective is to quantify differences in behavioral functioning between the chelation treatment group and the placebo control group. Analysis of mercury levels before and during the course of treatment will be used to confirm the expected DMSA-induced excretion of mercury and to identify differences among children in the extent of excretion. Our primary hypothesis is that, on average and relative to the control group, children with ASD who undergo chelation with DMSA will show greater improvements in communication and social behavior.

Conditions

Autism; Asperger's Disorder; Child Development Disorders, Pervasive

Keywords

Pervasive Developmental Disorder; Alternative Therapy; Autism; Asperger's Disorder; Clinical Trial; Autism Spectrum Disorder; ASD; Asperger Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

DMSA

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: lead

Locations

National Institute of Mental Health (NIMH), 9000 Rockville Pike

Bethesda, Maryland, United States

Countries

United States

References

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. doi: 10.1146/annurev.pa.30.040190.001431.

Reference Type: BACKGROUND

PMID: 2160791 (View on PubMed)

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. doi: 10.1054/mehy.2000.1281.

Reference Type: BACKGROUND

PMID: 11339848 (View on PubMed)

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. doi: 10.1081/clt-100100945.

Reference Type: BACKGROUND

PMID: 10930052 (View on PubMed)

Other Identifiers

06-M-0238

Identifier Type: -

Identifier Source: secondary_id

060238

Identifier Type: -

Identifier Source: org_study_id