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Completed

NCT Number: NCT00811083

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Southwest College of Naturopathic Medicine

Tempe, Arizona, 85252, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMSA - dimercaptosuccinic acid

Drug

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

Other names: Succimer

Primary outcomes

  1. Determine the effect of DMSA therapy on the symptoms of autism

    Time frame: 4 month

  2. 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

    Time frame: 4 months

Secondary outcomes

  1. Determine if the initial severity of autism correlates with the excretion of toxic metals

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Southwest College of Naturopathic Medicine

Other

Registry information

Official study title

DMSA Treatment of Children With Autism and Heavy Metal Toxicity

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 18, 2008
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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