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NCT00325572 · ClinicalTrials.gov registry record · Phase 1
Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
A Phase 1 study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT00325572 is a Phase 1 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 89 participants.
The verdict
NCT00325572, a Phase 1 study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc 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 copper/zinc 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 copper/zinc ratios greater than 2.0, 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 1.25, 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.
Interventions
- DRUG oral zinc and vitamin C supplements
- OTHER oral Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00325572
The ClinicalTrials.gov registry entry for NCT00325572 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which oral zinc and vitamin C supplements is the first listed.
NCT00325572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00325572 about?
NCT00325572 is a clinical study titled "Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism". There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc 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 ...
What is the current status of trial NCT00325572?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2006-11. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00325572?
The interventions under investigation include: oral zinc and vitamin C supplements (DRUG), oral Placebo (OTHER).
Who is sponsoring clinical trial NCT00325572?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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