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

NCT00811083 | Completed Phase 1

• 1 other identifier: DMSA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

autism; toxic metals; DMSA; dimercaptosuccinic acid; chelation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  1 month

Study Arms (2)

DMSA- 1 round

ACTIVE COMPARATOR

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

Drug: DMSA - dimercaptosuccinic acid

DMSA-7 rounds

ACTIVE COMPARATOR

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.

Drug: DMSA - dimercaptosuccinic acid

Interventions

DMSA - dimercaptosuccinic acid DRUG

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

Also known as: Succimer

DMSA- 1 round; DMSA-7 rounds

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southwest College of Naturopathic Medicine: lead

Study Sites (1)

Southwest College of Naturopathic Medicine

Tempe, Arizona, 85252, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Succimer

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds

Study Officials

• James B. Adams, PhD

  Southwest College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

• Matthew Baral, ND

  Southwest College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: May 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

US (1)