Autism Spectrum Disorder
Conditions
Brief summary
An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.
Detailed description
Children enrolled in Oak Hill School will enroll in this study and take micronutrient supplement once a day for 8 weeks period. Behavioral measures and metabolites taken from Dried Blood Spots (DBS) will be collected pre and post treatment. Behavioral measures will be taken again at 12 weeks, after 4 weeks of not dosing.
Interventions
DRUGMicronutrient
Subject will take micronutrient supplement daily for 8 weeks
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD. 2. ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation). 3. Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion criteria
1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 2. Taking multivitamins currently and unwilling to stop during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Autism Behavior Inventory, Short Form (ABI-S) | Baseline to Week 8 | The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (ASD) symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total range of score is between 0 and 72. Lower score indicates better performance. |
| Change in the Social Responsiveness Scale (SRS) | Baseline to Week 8 | SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants received the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It was delivered in a powder form and taken sublingually. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 11 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Autism Behavior Inventory - Short (ABI-S) ABI-S (Parent) | 25.3 units on a scale STANDARD_DEVIATION 3.5 | — |
| Autism Behavior Inventory - Short (ABI-S) ABI-S (Teacher) | 21.6 units on a scale STANDARD_DEVIATION 10.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 11 Participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Social Responsiveness Scale (SRS) SRS (Parent) | 94.4 units on a scale STANDARD_DEVIATION 23.8 | — |
| Social Responsiveness Scale (SRS) SRS (Teacher) | 69 units on a scale STANDARD_DEVIATION 24.1 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Change in the Autism Behavior Inventory, Short Form (ABI-S)
The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (ASD) symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total range of score is between 0 and 72. Lower score indicates better performance.
Time frame: Baseline to Week 8
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Change in the Autism Behavior Inventory, Short Form (ABI-S) | ABI-S (Parent) | -2.9 score on a scale |
| All Participants | Change in the Autism Behavior Inventory, Short Form (ABI-S) | ABI-S (Teacher) | -0.8 score on a scale |
Comparison: Null hypothesis was no improvement in mean ABI-S and SRS scores at the end of the study, compared to baselinep-value: <0.05t-test, 1 sided
Primary
Change in the Social Responsiveness Scale (SRS)
SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance.
Time frame: Baseline to Week 8
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Change in the Social Responsiveness Scale (SRS) | SRS (Parent) | -8.1 score on a scale |
| All Participants | Change in the Social Responsiveness Scale (SRS) | SRS (Teacher) | 0.8 score on a scale |