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IRCT201212012269N2 IRCT 2013-04-21 Vice chancellor for research, Guilan University of Medical Sciences Effect of ferrous sulfate on attention-deficit/hyperactivity disorder symptoms in children A survey of effect of iron supplementation(ferrous sulfate) versus placebo on attention-deficit/hyperactivity disorder symptoms in children under Methylphenidate treatment 2012-12-21 anticipated 50 Complete https://irct.ir/trial/1909 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Type of randomization: Blocked randomization The study medications (Ferrous sulfate and placebo tablets) will be indistinguishable in terms of appearance, weight and taste. The investigators together with the participants (children and their parents) will be blinded to the randomization lists until the end of the trial. "Double blind" will be used as a stringent way of study, to eliminate of unrecognized biases, and to achieve a higher scientific standard than “blind” or “non-blind" experiments. 2 Attention deficit/hyperactivity disorder. Intervention 1: Ferrous sulfate (brand name: Ferrous sulfate), 80 mg oral tablet, manufactured by Shahre Daru Co., daily for 3 months. Intervention 2: Placebo, oral tablet, manufactured by Shahre Daru Co., contains: Lactose- Avicel- Polyvinylpyrrolidone (PVP), daily for 3 months.
public Hamed Esmaili Gurabi
Faculty of medicine, Guilan University complex, 10th Km of Tehran road
Rasht Iran (Islamic Republic of) +98 13 1669 0099 esmaili.hamed@yahoo.com Guilan University of Medical Sciences scientific Elham Bidabadi, MD.
17th Shahrivar Hospital, Namjoo St.
Rasht Iran (Islamic Republic of) +98 13 1322 9524 bidabadi@mail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Children with attention-deficit/hyperactivity disorder based on DSM-IV TR and under Methylphenidate treatment 2. Lack of anemia (Hemoglobin lower than 11 g/dl) 3. Blood ferritin level lower than 30 ng/ml Exclusion criteria: 1. Comorbidity of attention-deficit/hyperactivity disorder with other psychiatric disorders 2. Serious and chronic medical disorders (such as malnutrition) 3. Mental retardation 4. Recent inflammation or infection 5. Use of psychopharmacological medications 6. Iron supplementation consumption during recent 3 months, or contraindication for use it. 7.Severe fever (because of pseudo increase in ferritin level) 8.Hypothyroidism (because of pseudo decrease in ferritin level) 4 years 15 years Both F90.0 A group of disorders characterized by an early onset (usually in the first five years of life), lack of persistence in activities that require cognitive involvement, and a tendency to move from one activity to another without completing any one, together Treatment - Drugs Treatment - Drugs Ferrous sulfate (brand name: Ferrous sulfate), 80 mg oral tablet, manufactured by Shahre Daru Co., daily for 3 months Placebo, oral tablet, manufactured by Shahre Daru Co., contains: Lactose- Avicel- Polyvinylpyrrolidone (PVP), daily for 3 months Ferritin. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, monobind kit, ELISA method. Hemoglobin. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, immunometric method with autoanalyzer. TIBC. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, Ziest Chem kit, fluorometry method. Iron. Timepoint: Before intervention, 3 months later. Method of measurement: Blood sampling, Ziest Chem kit, fluorometry method. Attention Deficit Hyperactivity Disorder (ADHD) index. Timepoint: First, Sixth, and twelfth weeks. Method of measurement: Conners' Parent Rating Scale (CPRS). Vice chancellor for research, Guilan University of Medical Sciences Approved 2012-10-23 Ethics committee of Guilan University of Medical Sciences Vice chancellor for research, Guilan University of Medical Sciences, West Shahid Beheshti Blvd. Rasht Iran (Islamic Republic of)