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IRCT20180503039517N5 IRCT 2020-09-26 Islamic Azad University Effects of vitamin D and/or aquatic exercise on IL-1β and IL-1RA serum levels and behavior of children with autism spectrum disorder Effects of vitamin D and/or aquatic exercise on IL-1β and IL-1RA serum levels and behavior of children with autism spectrum disorder 2020-08-18 anticipated 80 Complete https://irct.ir/trial/51171 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Eighty children aged 6-8 years with autism spectrum disorder are selected by the available sampling method. Each person is assigned a number. It is then used to create groups randomly using the RAND function in Excel software. Eventually, 20 people will be replaced in each group (three experimental groups and one control group), Blinding description: In this study, blood samples and laboratory analysis experts are also unaware of the type of intervention and participating groups. Statistical analysts are not aware of the individuals and how the research is conducted. N/A Autism Spectrum Disorder. Intervention 1: Intervention group: aquatic exercise (10 weeks, 2 session per week, 60 min training in pool). ٍEach session includes a 5-minute warm-up, 15-minute orientation training, 20-minute basic swimming skills, 15-minute free swim and a 5-minute cool down. Intervention 2: Intervention group: vitamin D supplementation (for 10 weeks, once a week orally, along with having dinner, 500000 IU vitamin D). Vitamin D3 will be provided by Dana Pharmaceutical Company. Intervention 3: Intervention group: Combination of aquatic exercise and vitamin D supplementation. In this group, participants will receive both the intervention of the first group (aquatic exercise for 10 weeks) and the second group (vitamin D supplementation for 10 weeks) according to the same process mentioned above. Intervention 4: Control group: Participants in this group are asked to continue their normal and routine programs during the research period, as before. But refrain from participating in new diet, medicine and physical activity programs. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Consult with competent authorities
public Fahimeh AdibSaber
Ansar Sport Club, 6th Ave, Keshavarz Ave, Valiasr Ave
Rasht Iran (Islamic Republic of) 4139617379 +98 13 3375 2906 adibsaber@iaurasht.ac.ir Islamic Azad University scientific Fahimeh AdibSaber
Ansar Sport Club, 6th Ave, Keshavarz Ave, Valiasr Ave
Rasht Iran (Islamic Republic of) 4139617379 +98 13 3375 2906 adibsaber@iaurasht.ac.ir Islamic Azad University Iran (Islamic Republic of) psychiatrist –diagnosed ASD (by Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V)) Male gender aged 6-8 years no change in any medical, dietary or behavior treatment during the study parental informed consent 6 years 8 years Male Having comorbid disability or other Neuro-cognitive disorders receiving vitamin D supplements in the last 6 months F84.0 Autistic disorder Lifestyle Lifestyle Lifestyle Lifestyle Intervention group: aquatic exercise (10 weeks, 2 session per week, 60 min training in pool). ٍEach session includes a 5-minute warm-up, 15-minute orientation training, 20-minute basic swimming skills, 15-minute free swim and a 5-minute cool down. Intervention group: vitamin D supplementation (for 10 weeks, once a week orally, along with having dinner, 500000 IU vitamin D). Vitamin D3 will be provided by Dana Pharmaceutical Company. Intervention group: Combination of aquatic exercise and vitamin D supplementation. In this group, participants will receive both the intervention of the first group (aquatic exercise for 10 weeks) and the second group (vitamin D supplementation for 10 weeks) according to the same process mentioned above. Control group: Participants in this group are asked to continue their normal and routine programs during the research period, as before. But refrain from participating in new diet, medicine and physical activity programs. IL-1B serum levels. Timepoint: One week before starting and one week after terminating of intervention. Method of measurement: Diaclone human kit for IL-1B. IL-1ra serum levels. Timepoint: One week before starting and one week after terminating of intervention. Method of measurement: ZellBio human kit for IL-1RA. Vitamin D serum level. Timepoint: One week before starting and one week after terminating of intervention. Method of measurement: Pars Azmoon human kit. Stereotypic behavior. Timepoint: One week before starting and one week after terminating of intervention. Method of measurement: Gars-2, stereotypic behaviors subscale. Islamic Azad University Approved 2020-08-17 Ethics committee of Rasht Azad University Medical Sciences Azad University of Rasht, Lakan Ave Rasht Guilan Iran (Islamic Republic of)