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

Primary Purpose

Autism, Pervasive Developmental Disorder

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oral zinc and vitamin C supplements
oral Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral zinc and vitamin C supplementation

Oral Placebo

Arm Description

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

Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.

Outcomes

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
Phase 2 was not initiated; no data was collected.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2006
Last Updated
May 13, 2019
Sponsor
Milton S. Hershey Medical Center
Collaborators
Thrasher Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00325572
Brief Title
Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Official Title
Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy to proceed to Phase 2
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Thrasher Research Fund

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Pervasive Developmental Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral zinc and vitamin C supplementation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Oral Placebo
Arm Type
Placebo Comparator
Arm Description
Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
Intervention Type
Drug
Intervention Name(s)
oral zinc and vitamin C supplements
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
Intervention Type
Other
Intervention Name(s)
oral Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
Phase 2 was not initiated; no data was collected.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette C Ramer, MD
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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

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