Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Condition: Autism; Pervasive Developmental Disorder
MeSH terms: Autistic Disorder; Developmental Disabilities; Autism Spectrum Disorder
Intervention: oral zinc and vitamin C supplements; oral Placebo
Intervention description: 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; 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 3 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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