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IRCT20131013014994N5 IRCT 2018-04-18 Kermanshah University of Medical Sciences effect of vitamin D on Autism Spectrum Disorders Effect of vitamin D supplementation on core symptoms and serum biomarkers (serotonin and IL-6) in children with autism spectrum disorders 2018-04-20 anticipated 48 Complete https://irct.ir/trial/14421 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, patients and researchers of type of intervention (complementary to vitamin D drops or placebo) are unaware of the groups, Randomization description: In order to prevent the bias before the time of the intervention, it is better to use the random allocation method to each of the two groups of intervention and random control. In this study, a simple randomization method will be used to carry out random allocation (allocation hiding). Became In this way, 50 cards that are identical in appearance are prepared on 25 numeric cards or code that identifies the intervention group, and on 25 other cards, the number or the two code that specifies the control group. Then, each eligible entry student will randomly pick one of these cards, with codes coded, which will determine the random allocation of patients to each of the groups (without the participants in the testing of the nature of the numbers one or two in The type of intervention that will be assigned will be notified.), Blinding description: In this study, nine individuals, not scholars, are aware of the allocation to the groups. For this purpose, the information gathered in the questionnaires is encoded by people other than the researcher or other key collaborators, so that the researcher and the participants in the plan do not encode and enter the computer during the categorization and placement of each individual in the intervention or control group. N/A autism spectrum disorders. Intervention 1: 15 drops of placebo are administered daily for three months. Intervention 2: Daily vitamin D supplements, 300 units per kilogram of body weight, up to a maximum of 6,000 units for three months are consumed. No - There is not a plan to make this available Justification or reason for not sharing IPD is Triales that began to fall ill on January 11, 1397 should have a release plan when registering their study protocol.
public Zohreh Javadfar
Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3828 1991 zohreh.javadfar@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr Hadi Abdollahzad
Public Health faculty, Next to the Farabi Hospital, Dolat Ababd blvd, Isar Square, Imam Hosein Exp
Kermanshah Iran (Islamic Republic of) 6719851351 +98 83 3828 1991 abdollahzad@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) The desire for parental collaboration The age range of 3 to 13 years The diagnosis of autism disorder based on DSM-5 criteria 3 years 13 years Both Reluctance to continue cooperation Children with significant hearing loss and vision loss Other neurological disorders such as cerebral palsy, phenylketonuria, seizure disorders History of head trauma, genetic abnormalities, premature children, children with nutritional and malnutrition problems, children with digestive problems, immune disorders, children with endocrine diseases, cardiovascular, pulmonary, kidney, liver Children two months prior to study Supplements or the following medications: vitamin A, vitamin D, fish liver oil, steroids, cimetidine, heparin, diuretics, digoxin, diltiazem and verapamil Children with serum vitamin D levels above 80 ng / ml F84.0 Autistic disorder Placebo Treatment - Drugs 15 drops of placebo are administered daily for three months. Daily vitamin D supplements, 300 units per kilogram of body weight, up to a maximum of 6,000 units for three months are consumed. Severity of autism. Timepoint: At the beginning of the study and 12 weeks after the start of treatment. Method of measurement: By Childhood Autism Rating Scale (CARS) - Aberrant Behavior Checklist-Community (ABC-C) Rating Scale. Evaluation of autism treatment. Timepoint: At the beginning of the study and 12 weeks after the start of treatment. Method of measurement: By Autism Treatment Evaluation Checklist. Vitamin D serum level. Timepoint: First and twelfth week of study. Method of measurement: Eliza. Serotonin serum level. Timepoint: First and twelfth week of study. Method of measurement: Eliza. Interleukin 6 serum level. Timepoint: First and twelfth week of study. Method of measurement: Eliza. Kermanshah University of Medical Sciences Approved 2018-02-28 Deputy of Research of Kermanshah University of Medical Sciences Shahid Beheshti St., Oil Field, Facing Taleghani Hospital, Building No. 2 of Kermanshah University of Medical Sciences, Research and Research Branch Kermanshah Kermanshah Iran (Islamic Republic of)