Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity - Full Text View

Purpose

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.

Condition	Intervention	Phase
Autism	Drug: DMSA - dimercaptosuccinic acid	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	DMSA Treatment of Children With Autism and Heavy Metal Toxicity

Resource links provided by NLM:

Drug Information available for: Succimer Dimercaptosuccinic acid

Genetic and Rare Diseases Information Center resources: Heavy Metal Poisoning

U.S. FDA Resources

Further study details as provided by Southwest College of Naturopathic Medicine:

Primary Outcome Measures:

Determine the effect of DMSA therapy on the symptoms of autism [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine if the initial severity of autism correlates with the excretion of toxic metals [ Time Frame: 1 month ] [ Designated as safety issue: No ]


Enrollment:	80
Study Start Date:	May 2005
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: DMSA- 1 round 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 dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off Other Name: Succimer
Active Comparator: 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.	Drug: DMSA - dimercaptosuccinic acid dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off Other Name: Succimer

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.

Eligibility


Ages Eligible for Study:	3 Years to 8 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811083

Locations


United States, Arizona
Southwest College of Naturopathic Medicine
Tempe, Arizona, United States, 85252

Sponsors and Collaborators

Southwest College of Naturopathic Medicine

Investigators


Principal Investigator:	James B. Adams, PhD	Southwest College of Naturopathic Medicine
Principal Investigator:	Matthew Baral, ND	Southwest College of Naturopathic Medicine

More Information


Responsible Party:	Matthew Baral and James B. Adams, Southwest College of Naturopathic Medicine
ClinicalTrials.gov Identifier:	NCT00811083 History of Changes
Other Study ID Numbers:	DMSA
Study First Received:	December 17, 2008
Last Updated:	December 17, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Southwest College of Naturopathic Medicine:


autism toxic metals DMSA dimercaptosuccinic acid chelation

Additional relevant MeSH terms:


Autistic Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Succimer Antidotes	Protective Agents Physiological Effects of Drugs Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016