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

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ClinicalTrials.gov Identifier: NCT00811083
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Southwest College of Naturopathic Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Drug: DMSA - dimercaptosuccinic acid Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: DMSA Treatment of Children With Autism and Heavy Metal Toxicity
Study Start Date : May 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: DMSA- 1 round
Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo
 Drug: DMSA - dimercaptosuccinic acid
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Other Name: Succimer
Active Comparator: DMSA-7 rounds
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.
 Drug: DMSA - dimercaptosuccinic acid
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Other Name: Succimer


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Determine if the initial severity of autism correlates with the excretion of toxic metals [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811083


Locations
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United States, Arizona
Southwest College of Naturopathic Medicine
Tempe, Arizona, United States, 85252
Sponsors and Collaborators
Southwest College of Naturopathic Medicine
Investigators
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Principal Investigator: James B. Adams, PhD Southwest College of Naturopathic Medicine
Principal Investigator: Matthew Baral, ND Southwest College of Naturopathic Medicine
More Information
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Responsible Party: Matthew Baral and James B. Adams, Southwest College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00811083    
Other Study ID Numbers: DMSA
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008
Keywords provided by Southwest College of Naturopathic Medicine:
autism
toxic metals
DMSA
dimercaptosuccinic acid
chelation
Additional relevant MeSH terms:
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Heavy Metal Poisoning
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Poisoning
Chemically-Induced Disorders
 Succimer
Antidotes
Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action