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

Southwest College of Naturopathic Medicine

Status and phase: Completed; Phase 2; Phase 1

Conditions: Autism

Treatments: Drug: DMSA - dimercaptosuccinic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00811083

DMSA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

DMSA- 1 round

Active Comparator group

Description:

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

Treatment:

Drug: DMSA - dimercaptosuccinic acid

DMSA-7 rounds

Active Comparator group

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.

Treatment:

Drug: DMSA - dimercaptosuccinic acid