Clinical trial NCT00811083: Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
Official title: DMSA Treatment of Children With Autism and Heavy Metal Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Autism
Keywords: autism
toxic metals
DMSA
dimercaptosuccinic acid
chelation
Lead sponsor: Southwest College of Naturopathic Medicine
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the effect of DMSA therapy on the symptoms of autism
timeFrame: 4 month
measure: 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
timeFrame: 4 months
Secondary outcomes:
measure: Determine if the initial severity of autism correlates with the excretion of toxic metals
timeFrame: 1 month
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Southwest College of Naturopathic Medicine
state: Arizona
Study officials:
affiliation: Southwest College of Naturopathic Medicine
name: James B. Adams, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest College of Naturopathic Medicine
name: Matthew Baral, ND
role: PRINCIPAL_INVESTIGATOR
References: