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

JRCT ID: jRCTs051190017

Registered date:09/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Autism spectrum disorder
• Date of first enrollment: 18/07/2018
• Target sample size: 72
• Study type: Interventional

Intervention(s)

Subjects are divided into the following 4 groups below, and capsules containing 25 mg of 5-aminolevulinic acid phosphate + 29 mg of sodium ferrous citrate are orally administered.
1.Take 1 capsule once per day, for the first 12 weeks. After 4 weeks washout, take 1 placebo capsule once per day, for the second 12 weeks.
2.Take 1 placebo capsule once per day, for the first 12 weeks. After 4 weeks washout, take 1 capsule once per day, for the second 12 weeks.
3.Take 6 capsules once per day, for the first 12 weeks. After 4 weeks washout, take 6 placebo capsules once per day, for the second 12 weeks.
4.Take 6 placebo capsules once per day, for the first 12 weeks. After 4 weeks washout, take 6 capsules once per day, for the second 12 weeks.

Outcome(s)

• Primary Outcome: 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 Outcome: We will evaluate gaze fixation time on social region by Gazefinder as quantitative behavior indices reflecting social deficits of subjects. 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.

Exclude criteria

1.Persons who cannot 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

Related Information

• Primary Sponsor: Matsuzaki Hideo
• Source(s) of Monetary Support: SBI Pharmaceuticals Co., Ltd.
• Secondary ID(s): UMIN000029757