AutismPhase 1/2NCT00811083
Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
A Phase 1/2 study testing DMSA - dimercaptosuccinic acid in people with Autism, run by Southwest College of Naturopathic Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Autism
- What is being tested?
- DMSA - dimercaptosuccinic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Apr 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Southwest College of Naturopathic Medicine
Tempe, Arizona, 85252
About this study
Official title: DMSA Treatment of Children With Autism and Heavy Metal Toxicity
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.
Read the 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.
- Conditions
- Autism
- Being tested
- DMSA - dimercaptosuccinic acid
- Keywords
- autism, toxic metals, DMSA, dimercaptosuccinic acid, chelation
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMSA - dimercaptosuccinic acidDrug
Also called Succimer
dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: DMSA - dimercaptosuccinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of DMSA therapy on the symptoms of autism
Measured: 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
Measured: 4 months
Secondary outcomes (1)
Determine if the initial severity of autism correlates with the excretion of toxic metals
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startMay 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwest College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Investigators
- James B. Adams, PhD, Principal investigator, Southwest College of Naturopathic MedicineMatthew Baral, ND, Principal investigator, Southwest College of Naturopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811083
- Sponsor's protocol ID
- DMSA
- Status last verified
- Dec 2008
- First submitted
- 17 Dec 2008
- Last updated
- 18 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DMSA Treatment of Children With Autism and Heavy Metal Toxicity
- ClinicalTrials.gov ID
- NCT00811083
- Acronym / sponsor ID
- DMSA
- Conditions
- Autism
- Keywords
- autism, toxic metals, DMSA, dimercaptosuccinic acid, chelation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Southwest College of Naturopathic MedicineUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMSA- 1 round | Active comparator | Drug: DMSA - dimercaptosuccinic acidSubjects receive 1 round of DMSA (10 mg/kg-dose, 9 doses over 3 days), followed by 3 months of placebo |
| DMSA-7 rounds | Active comparator | Drug: DMSA - dimercaptosuccinic acidParticipants 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
- Excretion of high amounts of toxic metals in phase one
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMSA - dimercaptosuccinic acidAlso: Succimerdose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off | Drug | DMSA- 1 round, DMSA-7 rounds |
Primary outcome
Determine the effect of DMSA therapy on the symptoms of autism
Time frame: 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
Time frame: 4 months
1 secondary outcome
Determine if the initial severity of autism correlates with the excretion of toxic metals
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James B. Adams, PhD principal investigator
Southwest College of Naturopathic Medicine
Matthew Baral, ND principal investigator
Southwest College of Naturopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DMSA - dimercaptosuccinic acid in people with Autism, run by Southwest College of Naturopathic Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of DMSA therapy on the symptoms of autism (time frame: 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2008.