Attention deficit hyperactivity disorder. Attention-deficit hyperactivity disorder, combined type
Conditions
Interventions
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: Con
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
7 Years to 14 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNarjes Hendouei
Mazandaran University of Medical Sciences
Outcome results
None listed