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

This study has been completed.
Sponsor:
Information provided by:
Southwest College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT00811083
First received: December 17, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Autism
Drug: DMSA - dimercaptosuccinic acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: DMSA Treatment of Children With Autism and Heavy Metal Toxicity

Resource links provided by NLM:


Further study details as provided by Southwest College of Naturopathic Medicine:

Primary Outcome Measures:
  • Determine the effect of DMSA therapy on the symptoms of autism [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine if the initial severity of autism correlates with the excretion of toxic metals [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811083

Locations
United States, Arizona
Southwest College of Naturopathic Medicine
Tempe, Arizona, United States, 85252
Sponsors and Collaborators
Southwest College of Naturopathic Medicine
Investigators
Principal Investigator: James B. Adams, PhD Southwest College of Naturopathic Medicine
Principal Investigator: Matthew Baral, ND Southwest College of Naturopathic Medicine
  More Information

No publications provided

Responsible Party: Matthew Baral and James B. Adams, Southwest College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00811083     History of Changes
Other Study ID Numbers: DMSA
Study First Received: December 17, 2008
Last Updated: December 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest College of Naturopathic Medicine:
autism
toxic metals
DMSA
dimercaptosuccinic acid
chelation

Additional relevant MeSH terms:
Autistic Disorder
Poisoning
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Chemically-Induced Disorders
Succimer
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014