UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034939 |
|---|---|
| Receipt number | 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 10:03:44 |
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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
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
matsuzah@u-fukui.ac.jp
Sponsor or person
Institute
Research Center for Child Mental Development, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039840
