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

Autism Clinical Trial

Official title:

DMSA Treatment of Children With Autism and Heavy Metal Toxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811083
• Other study ID #: DMSA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 17, 2008
• Last updated: December 17, 2008
• Start date: May 2005
• Est. completion date: April 2007

Study information

• Verified date: December 2008
• Source: Southwest College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Drug:
• DMSA - dimercaptosuccinic acid
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off

Locations

Country	Name	City	State
United States	Southwest College of Naturopathic Medicine	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Southwest College of Naturopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effect of DMSA therapy on the symptoms of autism		4 month	Yes
Primary	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	Yes
Secondary	Determine if the initial severity of autism correlates with the excretion of toxic metals		1 month	No