Evaluation of efficacy of Ritalin and ferrous sulfate in non-iron deficient children with attention-deficit/hyperactivity disorder (ADHD)

Clinical trial of efficacy evaluation of Ritalin alone and Ritalin with supplement of ferrous sulfate on improvement of hyperactivity and inattention symptoms of non-iron deficient children with attention-deficit/hyperactivity disorder (ADHD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201512262639N17

Enrollment

Registered

2016-04-16

Start date

2015-04-23

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. Disturbance of activity and attention

Interventions

Intervention 1: Tablet of 10 mg of Ritalin from Novartis Co, Switzerland in dosage of 2o mg/day divided in two doses and tablet of 50 mg ferrous sulfate from Daroupakhsh Co, Iran in dosage of 2 mg/kg/

Treatment - Drugs

Tablet of 10 mg of Ritalin from Novartis Co, Switzerland in dosage of 2o mg/day divided in two doses and tablet of 50 mg ferrous sulfate from Daroupakhsh Co, Iran in dosage of 2 mg/kg/day single dose

Tablet of ten mg of Ritalin from Novartis Co, Switzerland in dosage of 2o mg/day divided in two dose for three months

Eligibility

Sex/Gender

All

Age

6 Years to 11 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age range of 6-11 years; having ADHD based DSM-IV criteria; having at least score of 20 in ADHD diagnostic rating scale via parent interview; No iron deficiency (serum hemoglobin, iron and ferritin levels in normal limits); Not receiving iron combinations within the past two months; No use of any ADHD therapy Exclusion criteria: Acute or chronic medical disorders; epilepsy; tic; severe birth asphyxia; severe neonatal jaundice; vision problems; hearing disorders; other psychiatric disorders; irregular drugs usage; discontinuation of iron usage for more than one week

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
ADHD diagnostic rating scale. Timepoint: Before and three months after treatment. Method of measurement: Parent interview.;Parent Conner rating scales. Timepoint: Before and three months after treatment. Method of measurement: Parent interview.	—

Secondary

Measure	Time frame
Efficacy in more than 50% of reduction in ADHD diagnostic rating scale. Timepoint: Three months after treatment. Method of measurement: Parent interview.;Clinical side effects. Timepoint: Monthly until three months after treatment. Method of measurement: Asking from parents.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Razieh Fallah

Shahid Sadoughi University of Medical Sciences, Yazd, Iran

dr.raziehfallah@yahoo.com+98 35 3822 4000

Outcome results

None listed

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