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

The effect of vitamin D supplementation on behavioral disorders, serum serotonin and enteroquin-6 in children with autism spectrum disorders

A parallel, double-blind, placebo controled, randomized clinical trial

This study will be conducted on 48 children with autism spectrum disorders who are referred to an outpatient clinic of Mohammad Kermanshahi Hospital and the exceptional school of Kermanshah. Dietary intake, anthropometric data and blood biomarkers of children will be measured at the beginning and at the end of study. Participants were randomly assigned into vitamin D and placebo groups.

Inclusion criteria: the desire for parental collaboration, the age range of 3 to 13 years, the diagnosis of autism disorder based on DSM-5 criteria Exclusion criteria: 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, omega3, steroids, cimetidine, heparin, diuretics, digoxin, diltiazem and verapamil, children with serum vitamin D levels above 80ng/ml

Vitamin D group: receiving 300 units per kilogram of body weight of vitamin D drop to a maximum of 6000 units per day and the placebo group receiving the placebo drop

Evaluatation of behavioral changes (Aberrant Behavior Checklist-Community, Autism Treatment Evaluation Checklist and Childhood Autism Rating Scales) Vitamin D, interleukin 6 and serotonin biomarkers

Entering additional information

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.