Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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DMSA Treatment of Children With Autism and Heavy Metal Toxicity

Conditions
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Autism

Intervention / Treatment
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* Drug: DMSA - dimercaptosuccinic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DMSA- 1 round<br>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<br>* dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off<br>* Other names: Succimer;|
| Active Comparator: DMSA-7 rounds<br>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<br>* dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off<br>* Other names: Succimer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if the initial severity of autism correlates with the excretion of toxic metals |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, toxic metals, DMSA, dimercaptosuccinic acid, chelation