Autism Clinical Trial
Official title:
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 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.
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