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

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ClinicalTrials.gov Identifier: NCT00325572
Recruitment Status : Terminated (Lack of efficacy to proceed to Phase 2)
First Posted : May 15, 2006
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Jeanette C. Ramer, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE May 12, 2006
First Posted Date  ICMJE May 15, 2006
Results First Submitted Date  ICMJE February 12, 2019
Results First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Study Start Date  ICMJE November 2006
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
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 ]
Phase 2 was not initiated; no data was collected.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Official Title  ICMJE Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Pervasive Developmental Disorder
Intervention  ICMJE
  • Drug: 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
  • Other: 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
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Drug: oral zinc and vitamin C supplements
  • Placebo Comparator: 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.
    Intervention: Other: oral Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 13, 2019)
89
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325572
Other Study ID Numbers  ICMJE 23275
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanette C. Ramer, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Jeanette C Ramer, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
PRS Account Milton S. Hershey Medical Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP