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Effects of vitamin B6 in children with autism: a randomized controlled trial

Effects of vitamin B6 in children with autism: a randomized controlled trial - Vitamin B6 and autism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002650
Enrollment
100
Registered
2009-11-01
Start date
2009-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Interventions

After 2 weeks run-in period, pyridoxal 5&#39
-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
-phosphate in 4 weeks.

Sponsors

Department of Disaster Public Health
Lead Sponsor
Department of Pediatrics Tohoku University School of Medicine National Institute of Mental Health: National Center of Neurology and Psychiatry Yasuhara Children Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Pervasive Developmental Disorders Autism Society Japan Rating Scale (PARS) Clinical Global Impressions (CGI)

Secondary

MeasureTime frame
Aberrant Behavior Checklist (ABC) Social Maturity Scale

Countries

Japan

Contacts

Public ContactShinichi Kuriyama

Tohoku University International Research Institute of Disaster Science Department of Disaster Public Health

kuriyama@med.tohoku.a.cjo022-717-8104

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026