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

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Jeanette C. Ramer, Penn State University
ClinicalTrials.gov Identifier:
NCT00325572
First received: May 12, 2006
Last updated: January 13, 2013
Last verified: January 2013
  Purpose

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 thecurrently 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.


Condition Intervention Phase
Autism
Pervasive Developmental Disorder
Biological: oral zinc and vitamin C supplements
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Biological: 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
Placebo Comparator: 2
Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325572

Locations
United States, Pennsylvania
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Thrasher Research Fund
Investigators
Principal Investigator: Jeanette C Ramer, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Jeanette C. Ramer, Professor of Pediatrics, Penn State University
ClinicalTrials.gov Identifier: NCT00325572     History of Changes
Other Study ID Numbers: 23275
Study First Received: May 12, 2006
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Ascorbic Acid
Vitamins
Copper
Zinc
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Trace Elements

ClinicalTrials.gov processed this record on August 28, 2014