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IRCT201203167462N5 IRCT 2012-04-22 Tehran University of Medical Sciences Evaluating effects of Cyproheptadine and Folic acid in children with ADHD receiving Ritalin Evaluating and comparison of Cyproheptadine and Folic acid effects on appetite and hyperactivity and attention deficiency in children with ADHD receiving Ritalin 2012-04-18 anticipated 40 Complete https://irct.ir/trial/7928 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Attention Deficit Hyperactivity Disorder (ADHD). Intervention 1: Intervention group1: Methyl phenidate (Ritlin: 1mg/kg) combined with Cyproheptadin (Razi: 12 mg/day- 4mg before each meal). Intervention 2: Intervention group2: Methyl phenidate (Ritlin: 1mg/kg) combined with Folic acid (Alhavi: 5 mg/day).
public Seyed Ali Mostafavi
4th floor, Nutrition department, Health faculty, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 00 mostafavi.n80@hotmail.com Tehran University of Medical Sciences scientific Seyed Ali Mostafavi
4th floor, Nutrition department, Health faculty, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 00 mostafavi.n80@hotmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age range of 7-12; ADHD combined form; Clinical need to treat with Methylphenidate; parental consent and child ascent Exclusion criteria: any confounding co-morbiditis; any drug supplements or narcotics consumption; Children with history of major prenatal complications such as prematurity, low birth weight (reported by parents), any past or present psychosis, comorbid tourette syndrome, celiac, phenylketonuria, autism, or other persistent developmental disorders 7 years 12 years Both F90.0 Disturbance of activity and attention Treatment - Drugs Treatment - Drugs Intervention group1: Methyl phenidate (Ritlin: 1mg/kg) combined with Cyproheptadin (Razi: 12 mg/day- 4mg before each meal) Intervention group2: Methyl phenidate (Ritlin: 1mg/kg) combined with Folic acid (Alhavi: 5 mg/day) Attention deficiency score and Hyperactivity score. Timepoint: 0-2-4-8 weeks. Method of measurement: ADHD rating scale for children (complited by parents). Appetite score. Timepoint: 0-2-4-8 weeks. Method of measurement: Standard appetite questionnaire for chilldren. Sleep disorders score. Timepoint: 0-2-4-8 weeks. Method of measurement: Sleep disorders scale for chilldren (SDSC). Stimulants side effects. Timepoint: week 8. Method of measurement: Stimulants side effects questionnare. Tehran University of Medical Sciences Approved 2010-09-23 Tehran University of Medical Sciences Research Deputy of Tehran University of Medical Sciences, Keshavarz Avenue, Tehran. Iran Tehran Iran (Islamic Republic of)