Autism Spectrum Disorder Autism
Conditions
Interventions
Subjects are divided into the 2 groups and capsules containing 25 mg of 5-aminolevulinic acid phosphate + 29 mg of sodium ferrous citrate or placebo are orally administered once per day for 12 weeks.
food
Sponsors
Matsuzaki Hideo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A person who are under 18 years old at the time of obtaining consent. Gender does not matter. 2. A person who meet the clinical diagnosis of autism spectrum disorder according to the international diagnostic criteria DSM-5 and ADOS-2. 3. A person who has received sufficient explanation in participating in this study and has obtained the informed consent of the substitute or the subject himself / herself with sufficient understanding.
Exclusion criteria
Exclusion criteria: 1.Persons who cannot agree on their own will. 2.Persons who do not fall under the diagnosis of autistic spectrum disorder by clinical evaluation. 3.Persons who fall under fragile X syndrome. 4.Persons who merge neurological disease such as epilepsy. 5.Persons who merge liver abnormality/inflammatory disease. 6.Persons with drug allergies such as iron allergy. 7.Persons complicated with porphyria. 8.Persons who participated in other clinical trials within 3 months. 9.Pregnant women, persons who may become pregnant, persons who wish to become pregnant during the study period. 10. Persons taking supplements containing commercial 5-aminolevulinic acid phosphate or iron. 11.Persons judged by the principal investigator as inappropriate subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome are evaluated by differences in Stereotypic Behavior score of ABC-J (Aberrant Behavior Checklist Japanese Version) between groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| We evaluate ABC-J excluding stereotyped behavior, Autism Diagnostic Observation Schedule Second Edition(ADOS-2), Mental Health Questionnaire 12-item General Health Questionnaire (GHQ-12), Social Responsiveness Scale 2nd Edition (SRS2), Repetitive Behavior Scale-Revised (RBS-R), Sensory Profile scores as secondary outcome. We also evaluate plasma lipids Fraction, glutathione, tocopherol, 8-OHdG, coenzyme Q10, free radical scavenging activity, metallome, exosome, metabolome, FABP, GFAP, neurofilament as secondary outcome. Furthermore, as a clinical endpoint, the presence or absence and degree of impairment of daily living functions due to WHO-DAS will be evaluated. | — |
Contacts
Public ContactTomoko Taniguchi
University of Fukui
Outcome results
None listed