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IRCT20190602043790N1 IRCT 2020-06-06 Bagheiat-allah University of Medical Sciences Comparison of neurofeedback, vitamin D3 and combined neurofeedback with vitamin D3 supplementation in children with ADHD Comparison of neurofeedback, vitamin D3 and combined neurofeedback with vitamin D3 supplementation in children with ADHD: a randomized, double blind, Parallel-Group trial 2020-06-21 anticipated 120 Complete https://irct.ir/trial/43109 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is randomly blocks A, B, C, D. Patients fall into four categories, A, B, C or D depending on the order in which they study. Block A is the control group, Block B is neurofeedback, Block C vitamin D treatment and Block D combined neurofeedback and citamin D. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients, Blinding description: Treatment allocation was concealed from the psychiatrist and the data analyser who rated patients by using successively numbered, opaque, and sealed envelopes. participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware which experimental group they were assigned to. 3 Attention-Deficit Hyperactivity Disorder. Intervention 1: Control group:Patients do not receive any intervention during the 12 weeks. Intervention 2: Intervention group: Patients receive 1 30-minute neurofeedback training session every week for 12 weeks. Intervention 3: Intervention group: Patients take vitamin Pills (50,000 IU) weekly (manufactured by Poursina Pharmaceuticals) on a weekly basis for 12 weeks, depending on their weight. Intervention 4: Intervention group:Patients receive vitamin Pills (50,000 IU) weekly (manufactured by Poursina Pharmaceuticals) depending on their weight in addition 30-minute neurofeedback training session every 12 weeks. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to main outcome or like that , can be share. When: Start of access, 6 months after publishing the results To whom: Only people working in academic institutions could apply. Conditions: People who are conducting clinical trials in this field could apply. Where to obtain: By referring to the electronic address: s.hasanvandi@alzahra.ac.ir How to obtain: The applicant can receive information by registering the exact personal details. Comments:
public Saba Hasanvandi
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 s.hasanvandi@alzahra.ac.ir Bagheiat-allah University of Medical Sciences scientific Dr Saba Hasnvandi
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8804 0060 s.hasanvandi@alzahra.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of attention-deficit-hyperactivity disorder based on diagnostic and Statistical Manual of Mental Disorders (DSM) No use of Vitamin D3 before the study Lack of any psychotherapy during last 2 months Insufficiency 12 to 20 ng/mL (30 to 50 nmol/L) or Deficiency < 12 ng/mL (< 30 nmol/L). 5 years 17 years Both Parent's dissatisfaction to participate in study Psychiatric comorbidities (except for oppositional defiant disorder) seizure Systolic blood pressure over 12 Drug allergy F90.9 Attention-deficit hyperactivity disorder, unspecified type Behavior Treatment - Devices Treatment - Drugs Treatment - Drugs Control group:Patients do not receive any intervention during the 12 weeks. Intervention group: Patients receive 1 30-minute neurofeedback training session every week for 12 weeks. Intervention group: Patients take vitamin Pills (50,000 IU) weekly (manufactured by Poursina Pharmaceuticals) on a weekly basis for 12 weeks, depending on their weight. Intervention group:Patients receive vitamin Pills (50,000 IU) weekly (manufactured by Poursina Pharmaceuticals) depending on their weight in addition 30-minute neurofeedback training session every 12 weeks. Hyperactivity symptoms. Timepoint: Assessment of ADHD - attention deficit at the beginning of the study (before the intervention), weeks 4, 8 and 12 after the start of neurofeedback in intervention groups 2 and 4 and vitamin D3 consumption in intervention groups 3 and 4. Method of measurement: Parent and Teacher ADHD-RS-IV. Attention-Deficit symptoms. Timepoint: Assessment of ADHD - attention deficit at the beginning of the study (before the intervention), weeks 4, 8 and 12 after the start of neurofeedback in intervention groups 2 and 4 and vitamin D3 consumption in intervention groups 3 and 4. Method of measurement: Parent and Teacher ADHD-RS-IV. Impulsivity. Timepoint: Assessment of ADHD - attention deficit at the beginning of the study (before the intervention), weeks 4, 8 and 12 after the start of neurofeedback in intervention groups 2 and 4 and vitamin D3 consumption in intervention groups 3 and 4. Method of measurement: Parent and Teacher ADHD-RS-IV. Bagheiat-allah University of Medical Sciences Approved 2020-01-14 Ethics Committee of Baqiyatallah University of Medical Science Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran Tehran Tehran Iran (Islamic Republic of)