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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002650
Receipt No. R000003144
Scientific Title Effects of vitamin B6 in children with autism: a randomized controlled trial
Date of disclosure of the study information 2009/11/01
Last modified on 2013/10/24

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Basic information
Public title Effects of vitamin B6 in children with autism: a randomized controlled trial
Acronym Vitamin B6 and autism
Scientific Title Effects of vitamin B6 in children with autism: a randomized controlled trial
Scientific Title:Acronym Vitamin B6 and autism
Region
Japan

Condition
Condition Autism
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of vitamin B6 in children with autism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Pervasive Developmental Disorders Autism Society Japan Rating Scale (PARS)
Clinical Global Impressions (CGI)
Key secondary outcomes Aberrant Behavior Checklist (ABC)
Social Maturity Scale

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After 2 weeks run-in period, pyridoxal 5'-phosphate is given in doses of 5 mg/kg/d in the first 2 weeks. In the following 2 weeks, pyridoxal phosphate is given in doses of 10 mg/kg/d. Pyridoxal phosphate is given orally in powder or tablet form.
Interventions/Control_2 After 2 weeks run-in period, placebo is supplied in a powder or tablet form that is identical in appearance and taste to pyridoxal 5'-phosphate in 4 weeks.
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
3 years-old <=
Age-upper limit
14 years-old >=
Gender Male and Female
Key inclusion criteria 1) Meeting the ICD-10 criteria for Childhood autism F84.0, Atypical autism F84.1, Asperger's syndrome F84.5, or Other pervasive developmental disorders F84.8
2) Having symptom of hypersensitivity to sound or plasma glutamine concentration of <420 nmol/mL
Key exclusion criteria 1) History of epileptic seizures within 3 months prior to the study
2) Use of vitamin B6 supplements or drugs within 3 months prior to the study
3) History of homocystinuria or fragile X-syndrome.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Kuriyama
Organization Tohoku University International Research Institute of Disaster Science
Division name Department of Disaster Public Health
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL 022-717-8104
Email kuriyama@med.tohoku.a.cjo

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kuriyama
Organization Tohoku University International Research Institute of Disaster Science
Division name Department of Disaster Public Health
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL 022-717-8104
Homepage URL
Email kuriyama@med.tohoku.a.cjo

Sponsor
Institute Department of Disaster Public Health
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Pediatrics Tohoku University School of Medicine
National Institute of Mental Health: National Center of Neurology and Psychiatry
Yasuhara Children Clinic
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 国立精神・神経センター病院(東京都)
安原こどもクリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 20 Day
Last modified on
2013 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003144

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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