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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034939
Receipt No. R000039840
Scientific Title 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
Date of disclosure of the study information 2021/03/31
Last modified on 2021/11/02

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Basic information
Public title 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
Acronym RCT study for the nutritional therapy development of autism spectrum disorder
Scientific Title 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
Scientific Title:Acronym RCT study for the nutritional therapy development of autism spectrum disorder
Region
Japan

Condition
Condition Autism spectrum disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine the efficacy evaluation of oral administration of a combination of 5-aminolevulinic acid phosphate and sodium ferrous citrate for individuals (over 18 years) with autism spectrum disorder (ASD) for development of the nutritional therapy of ASD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 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, for the second 12 weeks.
Interventions/Control_2 Take 1 placebo capsule once per day, for the first 12 weeks. After 4 weeks washout, take 1 capsule (containing 25mg of 5-aminolevulinic acid phosphate + 29mg of Sodium Ferrous Citrate) once per day, for the second 12 weeks.
Interventions/Control_3 Take 6 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 6 placebo capsule once per day, for the second 12 weeks.
Interventions/Control_4 Take 6 placebo capsule once per day, for the first 12 weeks. After 4 weeks washout, take 6 capsule (containing 25mg of 5-aminolevulinic acid phosphate + 29mg of Sodium Ferrous Citrate) once per day, for the second 12 weeks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Hideo
Middle name
Last name Matsuzaki
Organization University of Fukui
Division name Research Center for Child Mental Development
Zip code 9101193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho,Yoshida-gun, Fukui
TEL 0776618803
Email matsuzah@u-fukui.ac.jp

Public contact
Name of contact person
1st name Hideo
Middle name
Last name Matsuzaki
Organization University of Fukui
Division name Research Center for Child Mental Development
Zip code 9101193
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776618803
Homepage URL
Email matsuzah@u-fukui.ac.jp

Sponsor
Institute Research Center for Child Mental Development, University of Fukui
Institute
Department

Funding Source
Organization SBI Pharmaceuticals
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Research Support Center, University of Fukui Hospital
Address 23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel 0776-61-8529
Email chiken@ml.u-fukui.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 29 Day
Date of IRB
2018 Year 02 Month 22 Day
Anticipated trial start date
2018 Year 07 Month 18 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 19 Day
Last modified on
2021 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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