Autism
Conditions
Keywords
autism, toxic metals, DMSA, dimercaptosuccinic acid, chelation
Brief summary
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
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.
Interventions
DRUGDMSA - dimercaptosuccinic acid
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Sponsors
Southwest College of Naturopathic Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
Phase One 1. Children with autism spectrum disorder 2. Age 3-8 years (up to the day before the ninth birthday). 3. 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: 1. Excretion of high amounts of toxic metals in phase one 2. 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) 3. 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Determine if the initial severity of autism correlates with the excretion of toxic metals | 1 month |
Countries
United States
Outcome results
None listed