Trial | NCT00811083  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    succimer ...

  • Study Participants

    80
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.
Study Started
May 31
2005
Primary Completion
Apr 30
2007
Study Completion
Apr 30
2007
Last Update
Dec 18
2008
Estimate

Drug DMSA - dimercaptosuccinic acid

dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off

  • Other names: Succimer

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.

Criteria 

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
No Results Posted