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

Primary Purpose

Autism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DMSA - dimercaptosuccinic acid
Sponsored by
Southwest College of Naturopathic Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring autism, toxic metals, DMSA, dimercaptosuccinic acid, chelation

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest College of Naturopathic Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DMSA- 1 round

DMSA-7 rounds

Arm Description

Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo

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.

Outcomes

Primary Outcome Measures

Determine the effect of DMSA therapy on the symptoms of autism
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

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2008
Last Updated
December 17, 2008
Sponsor
Southwest College of Naturopathic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00811083
Brief Title
Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
Official Title
DMSA Treatment of Children With Autism and Heavy Metal Toxicity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southwest College of Naturopathic Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
autism, toxic metals, DMSA, dimercaptosuccinic acid, chelation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMSA- 1 round
Arm Type
Active Comparator
Arm Description
Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo
Arm Title
DMSA-7 rounds
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DMSA - dimercaptosuccinic acid
Other Intervention Name(s)
Succimer
Intervention Description
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Primary Outcome Measure Information:
Title
Determine the effect of DMSA therapy on the symptoms of autism
Time Frame
4 month
Title
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 Measure Information:
Title
Determine if the initial severity of autism correlates with the excretion of toxic metals
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B. Adams, PhD
Organizational Affiliation
Southwest College of Naturopathic Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Baral, ND
Organizational Affiliation
Southwest College of Naturopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest College of Naturopathic Medicine
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85252
Country
United States

12. IPD Sharing Statement

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

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