Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism

Conditions
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Autism, Pervasive Developmental Disorder

Intervention / Treatment
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* Drug: oral zinc and vitamin C supplements
* Other: oral Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 3-8 years Diagnosis of autism spectrum disorder Serum copper/zinc ratio greater than 2.0 or as determined in phase 1 of the study Exclusion Criteria: Known chromosomal disorder or neurological disorders other than autism

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral zinc and vitamin C supplementation<br>Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks | Drug: oral zinc and vitamin C supplements<br>* Each child will be provided separate suspensions containing zinc and vitamin C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation<br>|
| Placebo Comparator: Oral Placebo<br>Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group. | Other: oral Placebo<br>* Each child will be provided separate Placebo suspensions C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Copper/Zinc Ratio of Children With Autism Compared to Typically Developing Children Phase 2: Change in Copper/Zinc Ratio With Supplementation of Zinc and Vitamin C | Phase 2 was not initiated; no data was collected. | 16 weeks |