Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325572
Status:
TERMINATED
Last Update Posted:
2019-07-17
First Post:
2006-05-12
Brief Title:
Evaluation and Treatment of CopperZinc Imbalance in Children With Autism
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Evaluation and Treatment of CopperZinc Imbalance in Children With Autism
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy to proceed to Phase 2
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are two phases to the study The first will examine serum copper and zinc levels and copperzinc ratio in children ages 3-8 who have autism and compare them to levels from same sex and age children who are developing typically The hypothesis is that there is a significant difference in the copperzinc ratio between young children who have autism and their typically developing peers
The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism Children with autism will be enrolled on the basis of copperzinc ratios greater than 20 and as determined to be statistically higher than typically developing children Measurements of serum copper zinc and unbound copper will be obtained prior to at the mid-point and end of the trial Those children whose ratios have not fallen below 125 the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial Detailed evaluation of language skills and a variety of behaviors will be evaluated prior to and after supplementation The study will be placebo-controlled and double blind Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study
The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism
The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism Children with autism will be enrolled on the basis of copperzinc ratios greater than 20 and as determined to be statistically higher than typically developing children Measurements of serum copper zinc and unbound copper will be obtained prior to at the mid-point and end of the trial Those children whose ratios have not fallen below 125 the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial Detailed evaluation of language skills and a variety of behaviors will be evaluated prior to and after supplementation The study will be placebo-controlled and double blind Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study
The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism
Detailed Description:
None
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