Trial Outcomes & Findings for Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism (NCT NCT00325572)
NCT ID: NCT00325572
Last Updated: 2019-07-17
Results Overview
Phase 2 was not initiated; no data was collected.
TERMINATED
PHASE1
89 participants
16 weeks
2019-07-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
PHASE I
STARTED
|
45
|
44
|
|
PHASE I
COMPLETED
|
45
|
44
|
|
PHASE I
NOT COMPLETED
|
0
|
0
|
|
PHASE ii
STARTED
|
0
|
0
|
|
PHASE ii
COMPLETED
|
0
|
0
|
|
PHASE ii
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism
Baseline characteristics by cohort
| Measure |
Zinc and Vitamin C Supplementation
n=45 Participants
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
|
Placebo Group
n=44 Participants
Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
45 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
4.5 years
STANDARD_DEVIATION 1.2 • n=93 Participants
|
5.9 years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
5.12 years
STANDARD_DEVIATION 1.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=93 Participants
|
44 participants
n=4 Participants
|
89 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Phase 2 was not initiated; no data was collected.
Phase 2 was not initiated; no data was collected.
Outcome measures
Outcome data not reported
Adverse Events
Zinc and Vitamin C Supplementation
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place