Status:
COMPLETED
Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
Lead Sponsor:
Southwest College of Naturopathic Medicine
Conditions:
Autism
Eligibility:
All Genders
3-8 years
Phase:
PHASE1
PHASE2
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...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00811083
Start Date
May 1 2005
End Date
April 1 2007
Last Update
December 18 2008
Active Locations (1)
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1
Southwest College of Naturopathic Medicine
Tempe, Arizona, United States, 85252