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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035175
Receipt No. R000038963
Scientific Title Safety and efficacy of rare sugar in children with autism spectrum disorder
Date of disclosure of the study information 2018/12/07
Last modified on 2018/12/17

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Basic information
Public title Safety and efficacy of rare sugar in children with autism spectrum disorder
Acronym Rare sugar for autism
Scientific Title Safety and efficacy of rare sugar in children with autism spectrum disorder
Scientific Title:Acronym Rare sugar for autism
Region
Japan

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

Objectives
Narrative objectives1 To investigate safety and efficacy (autistic symptom, improvement of obesity, circadian rhythm disorder, etc) of rare sugar in children with autism spectrum disorder.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event: condition or frequency of stool, blood examination, weight loss, hypertension, fatigue, irritability, dizziness, headache, edema
Key secondary outcomes Autistic symptom (DSM-5, PARS, CARS), autistic associated symptom (ABC-J, RBS-R), circadian rhythm, endocrine and metabolic examination (oxytocin, GLP-1), brain function (eye tracker, etc), developmental or intellectual evaluation (WISC-IV, etc)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Short-term study: the real medicine (a kind of monosaccharide) and placebo (D-glucose) is first administered to those assigned to group A and B for one month, respectively.
After a washout period of one month, as a cross over phase, the real medicine (a kind of monosaccharide) and placebo (D-glucose) is second administered to those assigned to group B and A for one month, respectively. Each drug dose are prescribed with low (0.2-0.3g/kg/day) and high (0.4-0.6g/kg/day) dose regimen.
Interventions/Control_2 Long-term study: after the short-term study for three months, the real medicine (a kind of monosaccharide) is administered to all participants for six months. The drug dose is prescribed with the same dose regimen of short-term study.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

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

Not applicable
Gender Male
Key inclusion criteria 1. The diagnosis for ASD was made based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
2. More than 12 years-old male
3. Parents or legal guardians of the participant provide written informed consent for participation.
Key exclusion criteria 1. Comorbid severe neurodegenerative, metabolic, and progressive disorder
2. Severe abnormalities of blood or electrocardiogram examination
3. Persistent diarrhea
4. Severe drug or food allergy
5. Those who changed one's medicine within three months
5. Responsible doctors judged a patient inappropriate for the trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Yamagata
Organization Jichi Medical University
Division name Department of Pediatrics
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7366
Email takanori@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Ikeda
Organization Jichi Medical University
Division name Department of Pediatrics
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi
TEL 0285-58-7366
Homepage URL
Email r0704ti@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization Jichi Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 12 Month 07 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 07 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038963

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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