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Lack of efficacy to proceed to Phase 2
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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral zinc and vitamin C supplementation | Active Comparator | 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 |
|
| Oral Placebo | Placebo Comparator | Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral zinc and vitamin C supplements | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeanette C Ramer, MD | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo Group | Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PHASE I |
| |||||||||||||
| PHASE ii |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Phase 2 was not initiated; no data was collected. | Posted | 16 weeks |
|
1 year
Adverse events were monitored / assessed for Phase 1 of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Trial was not completed and did not progress past Phase 1 of the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeanette C. Ramer MD | Milton S. Hershey Medical Center | 717 531-8414 | jramer2@hmc.psu.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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|
| oral Placebo | 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 |
|
| NOT COMPLETED |
|
| Placebo Group |
Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Placebo Group | Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group. | 0 | 44 | 0 | 44 | 0 | 44 |
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| D008670 |
| Metals |