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The effect of short-term co-administration of folate on aggressive behaviors in Attention Deficit Hyperactivity Disorder

The effect of short-term co-administration of folate on aggressive behaviors in Attention Deficit Hyperactivity Disorder (ADHD): a double blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108193930N11
Enrollment
40
Registered
2011-09-18
Start date
2011-08-19
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Attention Deficit Hyperactivity Disorder (ADHD). Hyperkinetic disorders

Interventions

Intervention 1: folic acid (5mg/day). Intervention 2: Placebo.
Treatment - Drugs
Placebo
folic acid (5mg/day)

Sponsors

Vice chancellor for research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 19 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) according to DSM-IV diagnostic criteria; children and adolescents aged 7 to 19 years old. Exclusion criteria: Self reported an allergic reaction to folic acid; kidney disease; being on dialysis; infection; anemia; epilepsy; taking medications such as phenytoin, methotrexate, nitrofurantoin, tetracycline barbiturates such as Phenobarbital, primidone; lack of providing written informed consent for participation; a diagnosed psychotic disorder; extensive use of nutritional folic acid supplements within the previous 3 months; behavior therapy or any other psychotherapy in the last three months or during this study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ADHD rating questionnaire. Timepoint: evey 30 days. Method of measurement: parent report.

Secondary

MeasureTime frame
Modified Overt Aggression Scale. Timepoint: evey 30 days. Method of measurement: parent report.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026