(1) Objectives: Investigate the effect of pharmaceutical composition of methylphenidate as well as a combination of magnesium and zinc and calcium for the treatment of attention deficit hyperactivity disorder (ADHD)
(2) Design: Randomized, Double blind, Placebo controlled, Single center, Phase 2 clinical trial
(3) Setting and conduct: After selecting the patients and achieving their parent’s consent, the method and the purpose of this study were explained to them. Then, a demographic information form was completed for each child separately. Patients were randomly divided into two groups using a table of random numbers
(4) Participants including major eligibility criteria:
Inclusion criteria: Aged 6 to 12 years; diagnosis of attention deficit hyperactivity disorder (ADHD) based on DSM-IV-TR diagnostic criteria
Exclusion criteria: Any simultaneous major psychiatric disease, except confrontational behavior and learning disorder
Target sample size: 40
(5) Intervention:
In the intervention group: Methylphenidate tablets orally used with a starting dose of 0.3 mg/kg, twice a day up to a final dose of 1 mg/kg within two weeks and continue treatment until 8 weeks after intervention and tablets containing 133 mg magnesium and 5 mg zinc and 333 mg calcium, one daily for 8 weeks
In the control group: Methylphenidate tablets were used orally with a starting dose of 0.3 mg/kg twice a day up to a final dose of 1 mg/kg within two weeks and continue treatment until 8 weeks after intervention and received placebo pills, once each day for 8 weeks
(6) Main outcome measures (variables): Medication, Side effects, Disorder severity