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Many children with autism have a reduced level of glutathione and a reduced ability to excrete mercury, resulting in elevated levels in their bodies as demonstrated by blood, hair, provoked urine, and baby tooth testing. Our earlier studies have demonstrated that DMSA, an FDA-approved medication for treating lead poisoning in children, is effective in increasing excretion of mercury and other toxic metals. Based on many clinical reports, we hypothesize that a 3-month treatment with glutathione and DMSA will result in a reduction of autistic symptoms in some children with autism.
This study will assess the safety and efficacy of the use of DMSA (an FDA-approved medication for treating lead poisoning in children) for the off-label treatment of symptoms of autism in children with autism and significant body burden of toxic metals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMSA- 1 round | Active Comparator | Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo |
|
| DMSA-7 rounds | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMSA - dimercaptosuccinic acid | Drug | dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effect of DMSA therapy on the symptoms of autism | 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 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if the initial severity of autism correlates with the excretion of toxic metals | 1 month |
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Inclusion Criteria:
Phase One
Phase Two:
Exclusion Criteria:
Phase One and Two:
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| Name | Affiliation | Role |
|---|---|---|
| James B. Adams, PhD | Southwest College of Naturopathic Medicine | Principal Investigator |
| Matthew Baral, ND | Southwest College of Naturopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest College of Naturopathic Medicine | Tempe | Arizona | 85252 | United States |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004113 | Succimer |
| ID | Term |
|---|---|
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| D009930 |
| Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |