AutismPhase 2NCT00376194
Mercury Chelation to Treat Autism
A Phase 2 study testing DMSA in people with Autism and Asperger's Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism, Asperger's Disorder, Child Development Disorders, Pervasive
- What is being tested?
- DMSA
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: An Investigation of the Efficacy of Mercury Chelation as a Treatment for Autism Spectrum Disorder
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.
Read more
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.
...
Read the 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.
- Being tested
- DMSA
- Keywords
- Pervasive Developmental Disorder, Alternative Therapy, Autism, Asperger's Disorder, Clinical Trial, Autism Spectrum Disorder, ASD, Asperger Disorder
- Medical subject headings
- Autistic Disorder, Asperger Syndrome, Child Development Disorders, Pervasive, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMSADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in social reciprocity.
Secondary outcomes (1)
Improvement in language skills, decrease in blood mercury levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startSep 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376194
- Sponsor's protocol ID
- 060238
- Other IDs
- 06-M-0238
- Status last verified
- Sep 2013
- First submitted
- 13 Sep 2006
- Last updated
- 18 Sep 2013
- Results posted
- No
Publications
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.
PubMed 2160791Bernard 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.
PubMed 11339848Chisolm 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.
PubMed 10930052
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Efficacy of Mercury Chelation as a Treatment for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT00376194
- Acronym / sponsor ID
- 060238
- Keywords
- Pervasive Developmental Disorder, Alternative Therapy, Autism, Asperger's Disorder, Clinical Trial, Autism Spectrum Disorder, ASD, Asperger Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Sep 2006
- Study completion
- Mar 2007
- First posted
- 14 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMSA | Drug | – |
Primary outcome
Improvement in social reciprocity.
1 secondary outcome
Improvement in language skills, decrease in blood mercury levels.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Background: PubMed 2160791Aposhian 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.
- Background: PubMed 11339848Bernard 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.
- Background: PubMed 10930052Chisolm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DMSA in people with Autism and Asperger's Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in social reciprocity.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376194, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.