Effect of vitamin D supplementation on core symptoms and serum biomarkers (serotonin and IL-6) in children with autism spectrum disorders

The purpose of this study was to evaluate the effect of vitamin D supplements on behavioral disorders and serum serotonin and enteroquin-6 serum biomarkers in children with autism spectrum disorders

The present study was conducted as a clinical trial with a control group randomly assigned to parallel, double-blind, randomized, 48-sampled patients. The phase of the trial did not apply to this study.

The present study is conducted on 48 children with autism spectrum disorders in girls and boys who are referred to an outpatient clinic of Dr. Mohammad Kermanshahi Hospital for 12 weeks, as well as an exceptional school and private and public health centers under the supervision of Welfare Organization of Kermanshah. To evaluate the dietary intake of children in the beginning of the study and the end of the twelfth week, two three-day feeding regimens (two normal days and one day off) are completed for children. In order to collect anthropometry data in the beginning of the study and the end of the twelfth week, weight, height, BMI and ... will be measured. Participants will be bled once at the beginning of the study, before the intervention, and once at the end of the study after 12 hours of fasting 10cc. Participants in the study were randomly divided into two groups of recipients of vitamin D supplementation and the placebo group receiving the same color and taste as the researchers and the participants were unaware.

The criteria for entering this study include: the desire for parental collaboration, the age range of 3 to 13 years, the diagnosis of autism disorder based on DSM-5 criteria; and the criteria for not attending the study include: 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 and 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

Children participating in the study are randomly assigned to the researchers themselves and the participants for unconscious grouping to receive 300 units per kilogram of body weight, supplementing vitamin D drops to a maximum of 6,000 units per day, and the placebo group receiving the same color and taste.

To evaluate behavioral changes in autistic children Aberrant Behavior Checklist-Community, Autism Treatment Evaluation Checklist and Childhood Autism Rating Scales; at the beginning and the end of the study is used. Vitamin D, interleukin 6 and serotonin biomarkers are also evaluated at the beginning and end of the study.

Deputy of Research of Kermanshah University of Medical Sciences

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.)

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.

Triales that began to fall ill on January 11, 1397 should have a release plan when registering their study protocol.