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

NCT ID: NCT00811083

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-04-30

Brief Summary

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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

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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.

Conditions

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Autism

Keywords

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autism toxic metals DMSA dimercaptosuccinic acid chelation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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DMSA- 1 round

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

Group Type ACTIVE_COMPARATOR

DMSA - dimercaptosuccinic acid

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

DMSA - dimercaptosuccinic acid

Intervention Type DRUG

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

Interventions

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DMSA - dimercaptosuccinic acid

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

Intervention Type DRUG

Other Intervention Names

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Succimer

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest College of Naturopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Southwest College of Naturopathic Medicine

Principal Investigators

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James B. Adams, PhD

Role: PRINCIPAL_INVESTIGATOR

Southwest College of Naturopathic Medicine

Matthew Baral, ND

Role: PRINCIPAL_INVESTIGATOR

Southwest College of Naturopathic Medicine

Locations

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Southwest College of Naturopathic Medicine

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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DMSA

Identifier Type: -

Identifier Source: org_study_id