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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Autism
Pervasive Developmental Disorder
Interventions Drug: oral zinc and vitamin C supplements
Other: oral Placebo
Enrollment 89
Recruitment Details Recruitment was begun in January, 2006. The participants were recruited from a developmental pediatrics outpatient clinic and comparison patients were recruited from a general pediatrics clinic and an allergy clinic.
Pre-assignment Details The Modified Checklist for Autism in Toddlers and the Social Responsiveness Scale were used as screens. 3 children were excluded from the comparison group because of scores outside the typical range. 4 children were excluded from the autism study group because they failed to meet criteria for autism using the Autism Diagnostic Interview-Revised.
Arm/Group Title Zinc and Vitamin C Supplementation Placebo Group
Hide Arm/Group 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.
Period Title: PHASE I
Started 45 44
Completed 45 44
Not Completed 0 0
Period Title: PHASE ii
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Zinc and Vitamin C Supplementation Placebo Group Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 45 44 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
<=18 years
45
 100.0%
44
 100.0%
89
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 89 participants
4.5  (1.2) 5.9  (1.9) 5.12  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 89 participants
Female
4
   8.9%
21
  47.7%
25
  28.1%
Male
41
  91.1%
23
  52.3%
64
  71.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 44 participants 89 participants
45 44 89
1.Primary Outcome
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
Hide Description Phase 2 was not initiated; no data was collected.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 2 was not initiated; no data was collected.
Arm/Group Title Zinc and Vitamin C Supplementation Placebo Group
Hide Arm/Group 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description Adverse events were monitored / assessed for Phase 1 of the study.
 
Arm/Group Title Zinc and Vitamin C Supplementation Placebo Group
Hide Arm/Group 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.
All-Cause Mortality
Zinc and Vitamin C Supplementation Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
Hide Serious Adverse Events
Zinc and Vitamin C Supplementation Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zinc and Vitamin C Supplementation Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/44 (0.00%) 
Trial was not completed and did not progress past Phase 1 of the study protocol.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeanette C. Ramer MD
Organization: Milton S. Hershey Medical Center
Phone: 717 531-8414
EMail: jramer2@hmc.psu.edu
Layout table for additonal information
Responsible Party: Jeanette C. Ramer, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00325572    
Other Study ID Numbers: 23275
First Submitted: May 12, 2006
First Posted: May 15, 2006
Results First Submitted: February 12, 2019
Results First Posted: July 17, 2019
Last Update Posted: July 17, 2019