Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376194
Status:
WITHDRAWN
Last Update Posted:
2013-09-18
First Post:
2006-09-13
Brief Title:
Mercury Chelation to Treat Autism
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Investigation of the Efficacy of Mercury Chelation as a Treatment for Autism Spectrum Disorder
Status:
WITHDRAWN
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether DMSA an oral chelating agent that removes mercury and other metals from the body is beneficial for children with autism DMSA is commonly used to treat autism although it has never been tested in a controlled study and there is no proof that it helps children with the disorder Support for its use is based on single-case reports of benefits of chelation with DMSA This study will help determine whether or not DMSA is useful for treating autism
Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33 pounds who have detectable but not toxic levels of mercury or lead in the blood and who have not previously received chelation therapy may be eligible for this study
Participants complete a medical history behavioral and psychological assessment and physical examination Blood hair urine and stool samples are collected for testing
Because DMSA can remove minerals the body needs such as zinc and iron as well as the toxic lead and mercury participants take a daily multivitamin supplement starting 1 month before beginning chelation therapy and continuing for the duration of treatment After 1 month of the supplementation regimen the children are assigned to receive DMSA or placebo for 12 weeks divided into six 2-week cycles They take the assigned drug 3 times a day on days 1 2 and 3 of each cycle and continue the multivitamin every day
The children are seen in the clinic immediately before and after the first third and sixth cycles At each checkup the parent or guardian answers a set of questions about the childs autism symptoms physical health and medication side effects Blood urine and stool samples are collected for laboratory testing
Children between 4 and 10 years of age with autism spectrum disorder who weigh at least 33 pounds who have detectable but not toxic levels of mercury or lead in the blood and who have not previously received chelation therapy may be eligible for this study
Participants complete a medical history behavioral and psychological assessment and physical examination Blood hair urine and stool samples are collected for testing
Because DMSA can remove minerals the body needs such as zinc and iron as well as the toxic lead and mercury participants take a daily multivitamin supplement starting 1 month before beginning chelation therapy and continuing for the duration of treatment After 1 month of the supplementation regimen the children are assigned to receive DMSA or placebo for 12 weeks divided into six 2-week cycles They take the assigned drug 3 times a day on days 1 2 and 3 of each cycle and continue the multivitamin every day
The children are seen in the clinic immediately before and after the first third and sixth cycles At each checkup the parent or guardian answers a set of questions about the childs autism symptoms physical health and medication side effects Blood urine and stool samples are collected for laboratory testing
Detailed Description:
Chelation of metals is widely used in the community to treat individuals with Autism Spectrum Disorder ASD with some surveys estimating that 1 in 12 children with autism have undergone chelation This widespread use reflects the hypothesis that many cases of ASD are caused by exposure to thimerosal an ethylmercury-based compound used previously in the US as a vaccine preservative for routine childhood immunizations The prevalent use of chelation therapy stands in stark contrast with the lack of scientific or clinical evidence of efficacy and creates a public health imperative for empiric data Thus we propose a controlled trial of the effects of chelation on the core behavioral symptoms and overall functioning of children with ASD The present investigation is a double-blind randomized placebo-controlled study of the oral chelating agent meso-23-dimercaptosuccinic acid DMSA succimer among 120 children ages four to ten years who meet criteria for ASD Pre- and post-treatment behavioral ratings will be used to evaluate the efficacy of chelation In addition children will undergo comprehensive medical history physical examination and laboratory analyses
Our objective is to quantify differences in behavioral functioning between the chelation treatment group and the placebo control group Analysis of mercury levels before and during the course of treatment will be used to confirm the expected DMSA-induced excretion of mercury and to identify differences among children in the extent of excretion Our primary hypothesis is that on average and relative to the control group children with ASD who undergo chelation with DMSA will show greater improvements in communication and social behavior
Our objective is to quantify differences in behavioral functioning between the chelation treatment group and the placebo control group Analysis of mercury levels before and during the course of treatment will be used to confirm the expected DMSA-induced excretion of mercury and to identify differences among children in the extent of excretion Our primary hypothesis is that on average and relative to the control group children with ASD who undergo chelation with DMSA will show greater improvements in communication and social behavior
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-M-0238 | None | None | None |