Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00811083 |
Recruitment Status :
Completed
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism | Drug: DMSA - dimercaptosuccinic acid | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | DMSA Treatment of Children With Autism and Heavy Metal Toxicity |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: DMSA- 1 round
Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo
|
Drug: DMSA - dimercaptosuccinic acid
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Other Name: Succimer |
Active Comparator: DMSA-7 rounds
Participants receive 7 rounds of DMSA over 4 months; each round consists of 3 days of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 11 days off (no treatment), and then repeating.
|
Drug: DMSA - dimercaptosuccinic acid
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Other Name: Succimer |
- Determine the effect of DMSA therapy on the symptoms of autism [ Time Frame: 4 month ]
- Determine the safety of DMSA therapy by pre/post assessment of complete blood count, standard chem panel including liver/kidney function, and excretion of essential minerals [ Time Frame: 4 months ]
- Determine if the initial severity of autism correlates with the excretion of toxic metals [ Time Frame: 1 month ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Phase One
- Children with autism spectrum disorder
- Age 3-8 years (up to the day before the ninth birthday).
- At least a two-month history of taking a multi-vitamin/mineral supplement with at least the RDA of zinc, and continuing to take that during Phase One and Two.
Phase Two:
- Excretion of high amounts of toxic metals in phase one
- Normal kidney/liver function, serum transaminases, and Complete Blood Count (CBC) (based on a blood test which will be conducted as part of Phase Two)
- No changes in medication, supplements, diet, or behavioral interventions during the study
Exclusion Criteria:
Phase One and Two:
- No mercury amalgam dental fillings.
- No previous use of DMSA or other prescription chelators (except for 1-time challenges).
- No anemia or currently being treated for anemia due to low iron.
- No known allergies to DMSA
- No liver or kidney disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811083
United States, Arizona | |
Southwest College of Naturopathic Medicine | |
Tempe, Arizona, United States, 85252 |
Principal Investigator: | James B. Adams, PhD | Southwest College of Naturopathic Medicine | |
Principal Investigator: | Matthew Baral, ND | Southwest College of Naturopathic Medicine |
Responsible Party: | Matthew Baral and James B. Adams, Southwest College of Naturopathic Medicine |
ClinicalTrials.gov Identifier: | NCT00811083 |
Other Study ID Numbers: |
DMSA |
First Posted: | December 18, 2008 Key Record Dates |
Last Update Posted: | December 18, 2008 |
Last Verified: | December 2008 |
autism toxic metals DMSA dimercaptosuccinic acid chelation |
Heavy Metal Poisoning Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Poisoning Chemically-Induced Disorders |
Succimer Antidotes Protective Agents Physiological Effects of Drugs Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |