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

December 17, 2008 updated by: Southwest College of Naturopathic Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85252
        • Southwest College of Naturopathic Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Succimer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the effect of DMSA therapy on the symptoms of autism
Time Frame: 4 month
4 month
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine if the initial severity of autism correlates with the excretion of toxic metals
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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