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IRCT20120314009297N3 IRCT 2018-04-30 Mazandaran University of Medical Sciences The effect of ferrous sulphate on the treatment of symptoms in children with attention deficit hyperactivity disorder Efficacy and safety of ferrous sulphate add-on standard treatment regimen for children with attention-deficit hyperactivity disorder in 7- to 14 year-Old without iron deficiency and anemia : A 12 weeks randomized, open-label, parallel group Study 2017-03-21 anticipated 38 Complete https://irct.ir/trial/30292 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on random numbers and 1: 1 ratio in treatment group and control group. 3 Attention deficit hyperactivity disorder. Intervention 1: Intervention group: receive ferrous sulphate tablet with a dose of 1 mg / kg according to elemental iron for 12 weeks along with their standard therapeutic regimen. Intervention 2: Control group: receive their standard therapeutic regimen alone for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet - its release plan is still unclear
public Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 7-14 years old children Diagnosed attention deficit hyperactivity disorder children by two psychiatrists and based on DSM-V and without iron deficiency and anemia (Serum ferritin above 15 μg /L and serum hemoglobin equal to or greater than 11 g /dl ) All patients are on standard treatment regimen for attention-deficit hyperactivity disorder for at least 3 months and a stable dose for at least 1 month. 7 years 14 years Both Acute phase of the disease Psychiatric comorbidity as defined by DSM-V (bipolar disorder, Major depressive disorder) Mental retardation Neurological diseases such as delirium, seizure, traumatic brain injury Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values Hypersensitivity to iron sulphate Previous treatment with any enriched medical products with iron at least 2 months before the initiation Unwillingness of the patient or his guardian to participate in the study F90.2 Attention-deficit hyperactivity disorder, combined type Treatment - Drugs Other Intervention group: receive ferrous sulphate tablet with a dose of 1 mg / kg according to elemental iron for 12 weeks along with their standard therapeutic regimen Control group: receive their standard therapeutic regimen alone for 12 weeks Emotional and behavioral problems. Timepoint: At the baseline and on the 45th and 90th days. Method of measurement: Strengths and Difficulties Questionnaire (SDQ). Severity of symptoms in hyperactivity, impulsivity and cognitive impairment in children with ADHD. Timepoint: At the baseline and on the 45th and 90th days. Method of measurement: Rutter Behavioral Disorder Questionnaire. Severity of symptoms in hyperactivity, impulsivity and cognitive impairment in children with ADHD. Timepoint: At the baseline and on the 45th and 90th days. Method of measurement: Conners' Parent Rating Scale. Serum iron level. Timepoint: At the baseline and on the 90th day. Method of measurement: ELISA Kit. Serum ferritin level. Timepoint: At the baseline and on the 90th day. Method of measurement: ELISA Kit. Hemoglobin; Hematocrit. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory data. Total iron-binding capacity (TIBC). Timepoint: At the baseline and on the 90th day. Method of measurement: ELISA Kit. Height. Timepoint: At the baseline and on the 90th day. Method of measurement: Height gauge. Weight. Timepoint: At the baseline and on the 90th day. Method of measurement: Scales. Waist circumference. Timepoint: At the baseline and on the 90th day. Method of measurement: Tape. Body mass index. Timepoint: At the baseline and on the 90th day. Method of measurement: Using the formula kilograms per square meter of height(Kg/m2). Serum total cholesterol level. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit. Low-density lipoprotein(LDL). Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit. High density lipoprotein (HDL). Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit. Serum triglyceride level. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit. Fasting blood sugar. Timepoint: At the baseline and on the 90th day. Method of measurement: Laboratory kit. Mazandaran University of Medical Sciences Approved 2017-06-06 Ethics committee of Mazandaran University of Medical Sciences Moallem street, Moallem square, Vice chancellor for research Sari Mazandaran Iran (Islamic Republic of)