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

Phase 1

Completed

• Conditions: Autism
• Interventions: Drug: DMSA - dimercaptosuccinic acid

• Registration Number: NCT00811083
• Lead Sponsor: Southwest College of Naturopathic Medicine

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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-12
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Last Update Submitted: 2008-12-17
• Study First Posted: 2008-12-18
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMSA- 1 round	DMSA - dimercaptosuccinic acid	Subjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo
DMSA-7 rounds	DMSA - dimercaptosuccinic acid	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.

Primary Outcome Measures

Name	Time	Method
Determine the effect of DMSA therapy on the symptoms of autism	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	4 months

Secondary Outcome Measures

Name	Time	Method
Determine if the initial severity of autism correlates with the excretion of toxic metals	1 month

Trial Locations

Locations (1)

Southwest College of Naturopathic Medicine; 🇺🇸 Tempe, Arizona, United States