UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000035175
Receipt number	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 11:08:58

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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

Autism spectrum disorder

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

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

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

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 or person

Institute

Jichi Medical University

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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