RCT study for the nutritional therapy development of ASD children

JRCT ID: jRCTs051210168

Registered date:03/02/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Autism Spectrum Disorder
• Date of first enrollment: 06/04/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: The primary outcome are changes before and after the intervention in stereotyped behavior scores of participants (ASD children who are under 18 years old) by ADOS-2 (Autism Diagnostic Observation Schedule Second Edition) and ABC (Aberrant Behavior Checklist).
• Secondary Outcome: ADOS-2 and ABC-J (except for stereotyped behavior) , GHQ-12 (12-item General Health Questionnaire), SRS2 (Social Responsiveness Scale 2nd Edition), RBS-R (Repetitive Behavior Scale-Revised), Sensory Profile are evaluated. In plasma, lipid fraction, Glutathione, tocopherol, 8OHdG, coenzyme Q10, free radical scavenging activity, metalome, exosome, metabolome, FABP, GFAP, and neurofilaments are evaluated. Furthermore, the presence or absence and degree of impairment of daily living functions due to WHO-DAS are evaluated as clinical endpoints. In addition, nausea, vomiting, fever, liver dysfunction and allergies are confirmed or measured to evaluate as safety endpoints.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 18age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Matsuzaki Hideo