Effect of omega-3 on treatment of hyperactive children

Effect of omega-3 supplements as complementary treatment with methylphenidate in children with attention-deficit/hyperactivity disorder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016050918927N2

Enrollment

Registered

2016-07-06

Start date

2015-04-21

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). Disturbance of activity and attention

Interventions

Intervention 1: Methylphenidate tablet with a dose of 0.5-1 mg/kg/day plus omega-3 capsule with a dose of 300 mg for a duration of 6 weeks. Intervention 2: Methylphenidate tablet with a dose of 0.5-1

Treatment - Drugs

Methylphenidate tablet with a dose of 0.5-1 mg/kg/day plus omega-3 capsule with a dose of 300 mg for a duration of 6 weeks

Methylphenidate tablet with a dose of 0.5-1 mg/kg/day plus placebo for a duration of 6 weeks

Eligibility

Sex/Gender

All

Age

7 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children between 7-12 aged; ADHD diagnosis by expert pediatric psychology physician using DSM diagnosis index; No prevention for Omega-3 supplements; IQ index above 70; Without other psychology disorders; No intake of Omega-3 supplements since 2 months ago; Intake of methylphenidate tablet with a dose of 0.5-1 mg/kg/day as a medical treatment Exclusion criteria:Stop the treatment by the child or parents; incorrect intake of the drug by the child; change the treatment method; Stop the treatment due to the side effects of the drug; Acute physical disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hyperactivity. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Score of Conners questionnaire.;Inattention. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Score of Conners questionnaire.;Impulsivity. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Score of Conners questionnaire.	—

Measure

Time frame

Hyperactivity. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Score of Conners questionnaire.;Inattention. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Score of Conners questionnaire.;Impulsivity. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Score of Conners questionnaire.

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Secondary

Measure	Time frame
Abdominal pain. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Ritaline and omega-3 side effects questionnaire.;Diarrhea. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Ritaline and omega-3 side effects questionnaire.;Epistaxis. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Ritaline and omega-3 side effects questionnaire.	—

Measure

Time frame

Abdominal pain. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Ritaline and omega-3 side effects questionnaire.;Diarrhea. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Ritaline and omega-3 side effects questionnaire.;Epistaxis. Timepoint: Befor treatment and 6 weeks following end of treatment. Method of measurement: Ritaline and omega-3 side effects questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Vosoughian

Medical University of Tabriz

samira_v.1987@yahoo.com+98 41 3333 5088

Outcome results

None listed

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