Double blinded randomized placebo controlled trial to examine if intake of 5-aminolevulinic acid supplement can improve clinical symptoms of individuals with Autism Spectrum Disorder

Double blinded randomized placebo controlled trial to examine if intake of 5-aminolevulinic acid supplement can improve clinical symptoms of individuals with Autism Spectrum Disorder - RCT study for the nutritional therapy development of autism spectrum disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034939

Enrollment

Registered

2021-03-31

Start date

2018-07-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Interventions

Take 1 capsule (containing 25mg of 5-aminolevulinic acid phosphate + 29mg of Sodium Ferrous Citrate) once per day, for the first 12 weeks. After 4 weeks washout, take 1 placebo capsule once per day, f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A person who has undergone clinical diagnosis of the autism spectrum disorder by DSM5 at a medical institution in Japan and has obtained the informed consent by himself concerning participation in this study.

Exclusion criteria

Exclusion criteria: 1.Persons who can not agree on their own will 2.As a result of clinical evaluation, those who do not fall under the diagnosis of autistic spectrum disorder 3.Persons who fall under fragile X syndrome 4.Persons who merge neurological diseases such as epilepsy 5.Person who merges liver abnormality / inflammatory disease 6.Patients with drug allergies such as iron allergy 7.Patients complicated with porphyria 8.Persons who participated in other clinical trials within 3 months 9.Persons who have been judged by the principal investigator as inappropriate subject

Design outcomes

Primary

Measure	Time frame
The primary outcome are changes in GHQ12 (12 item General Health Questionnaire Japanese version), SRS2 (Social Responsiveness Scale 2nd Edition), ADHD-RS (Attention Deficit Hyperactivity Disorder rating scale) and ABC (The Aberrant Behavior Checklist) before and after each administration period.	—

Secondary

Measure	Time frame
We will evaluate gaze fixation time on social region by Gazefinder as quantitative behavior indices reflecting social deficits of subjects. In order to investigate mitochondrial abnormality of the subjects, we will extract lymphocytes from peripheral blood of them and examine profiles of mitochondrial respiration and glycolysis by using extracellular flux analysis.	—

Countries

Japan

Contacts

Public ContactHideo Matsuzaki

University of Fukui Research Center for Child Mental Development

matsuzah@u-fukui.ac.jp0776618803

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026