UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002650 |
|---|---|
| Receipt number | 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 09:09:46 |
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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
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
kuriyama@med.tohoku.a.cjo
Sponsor or person
Institute
Department of Disaster Public Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003144
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
