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

Phase 1

Terminated

Conditions: Autism
Pervasive Developmental Disorder

Interventions: Drug: oral zinc and vitamin C supplements
Other: oral Placebo

Registration Number: NCT00325572

Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 89

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral zinc and vitamin C supplementation	oral zinc and vitamin C supplements	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
Oral Placebo	oral Placebo	Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.

Primary Outcome Measures

Name	Time	Method
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	16 weeks	Phase 2 was not initiated; no data was collected.

Secondary Outcome Measures