Autism, Pervasive Developmental Disorder
Conditions
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.
Interventions
DRUGoral 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
OTHERoral 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
Sponsors
Thrasher Research Fund
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 16 weeks | Phase 2 was not initiated; no data was collected. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 45 |
| 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. | 44 |
| Total | 89 |
Baseline characteristics
| Characteristic | Placebo Group | Zinc and Vitamin C Supplementation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 44 Participants | 45 Participants | 89 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.9 years STANDARD_DEVIATION 1.9 | 4.5 years STANDARD_DEVIATION 1.2 | 5.12 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 44 participants | 45 participants | 89 participants |
| Sex: Female, Male Female | 21 Participants | 4 Participants | 25 Participants |
| Sex: Female, Male Male | 23 Participants | 41 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 44 |
| other Total, other adverse events | 0 / 45 | 0 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 |
Outcome results
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.
Time frame: 16 weeks
Population: Phase 2 was not initiated; no data was collected.