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

NCT ID: NCT00325572

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Autism; Pervasive Developmental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral zinc and vitamin C supplementation

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

Group Type: ACTIVE_COMPARATOR

oral zinc and vitamin C supplements

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

oral Placebo

Intervention Type: OTHER

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

Interventions

oral zinc and vitamin C supplements

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

Intervention Type: DRUG

oral Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thrasher Research Fund

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeanette C. Ramer

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanette C Ramer, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Locations

Penn State Children's Hospital

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

23275

Identifier Type: -

Identifier Source: org_study_id