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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201402043930N33 |
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Date of registration:
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2014-08-16 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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short-term co-administration of acid folicfor treating children and adolescents with autism
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Scientific title:
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Double blind randomized controlled clinical trial of the effect of short-term co-administration of acid folic on children and adolescents with autism |
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Date of first enrolment:
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2014-02-03 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/4112 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Ahmad Ghanizadeh
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Address:
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Hafez Hospital
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Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 1627 3070 |
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Email:
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ghanizad@sina.tums.ac.ir |
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Affiliation:
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Shiraz University of Medical sciences |
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Name:
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Parisa Ansarifar
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Address:
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Hafez Hospita
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Shiraz
Iran (Islamic Republic of) |
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Telephone:
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+98 71 1627 3070 |
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Email:
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Ansarifar_p@yahoo.com |
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Affiliation:
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Shiraz University of Medical sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: Autism according to DSM-IV diagnostic criteria; aged 3 to 19 years old.
Exclusion Criteria: primary diagnosis of a psychotic disorder; active substance abuse or dependence; unstable medical condition.
Exclusion criteria:
Age minimum:
3 years
Age maximum:
19 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pervasive developmental disorders.
Childhood autism
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Childhood autism
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Intervention(s)
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Intervention 1: Acid folic (5mg/day)+ risperidone (0.5 to 3 mg/day). Intervention 2: Placebo + risperidone (0.5 to 3 mg/day).
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Placebo
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Treatment - Drugs
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Acid folic (5mg/day)+ risperidone (0.5 to 3 mg/day)
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Placebo + risperidone (0.5 to 3 mg/day)
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Primary Outcome(s)
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Irritability. Timepoint: Every 4 weeks. Method of measurement: Abbrant Behavior Checklist.
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Secondary Outcome(s)
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Adverse effects. Timepoint: Week 2, 4, and 8. Method of measurement: checklist.
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Source(s) of Monetary Support
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Vice chancellor for research, Shiraz University of Medical sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Shiraz University of Medical Sceinces
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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