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IRCT20190313043039N1 IRCT 2019-04-19 Tabriz University of Medical Sciences Effect of vitamin D supplements in schizophrenia The effect of the vitamin D3 on the metabolic parametrs, serum levels of the glycogen synthase kinase-3, β catenin, BDNF, S100B and ZAG in schizophrenic patients who have vitamin D3 deficiency 2019-04-21 anticipated 46 Complete https://irct.ir/trial/38437 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A total of 46 patients admitted to Razi Hospital in Tabriz were selected by simple sampling.In order to blinding, extraction of random numbers and their readings and assignment to the two groups (the odd numbers of the control group, paird numbers of the intervention group) will be carried out by the assistant researcher; The number of 46 envelopes with numbers 1 to 46 was prepared and inside them the numbers extracted from the random numbers table, Blinding description: Vitamin D and their placebo will be prepared by the pharmaceutical company in a completely similar shape, color and smell. The sequencing of allocation and preparation of pills will be done by non-contributing people.The type of the medications (vitamin D or placebo) will not be known to the researcher, nurses and patients. 3 SCHIZOPHRENIA. Intervention 1: Intervention group: Patients with schizophrenia who receive a dose of 2000 IU Vitamin D(Prepared by Dana Pharmaceuticals Inc.) per day(after lunch). Intervention 2: Control group:Schizophrenic patients who are randomly assigned to the control group and will receive a placebo (provided by the Dana Pharmaceuticals Company) for 8 weeks. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal. When: Start the access period immediately after printing the results To whom: Academic researchers Conditions: - Where to obtain: Refer to the email address How to obtain: Requests will be sent by email and the data will be available after checking the email Comments:
public Parinaz Kalejahi
Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138765878 +98 41 3334 0634 parinaz.kalejahi@gmail.com Tabriz University of Medical Sciences scientific Parinaz Kalejahi
Tabriz University of Medical Sciences, Attar Nishabouri St., Tabriz, I. R. Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3334 0634 parinaz.kalejahi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) People with schizophrenia admitted to Razi Hospital The age range of 18-65 years old in men and the age range of 18-50 years in women Diagnosis of schizophrenia based on the DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) and Psychiatrist's Confirmation PANSS score above 70 Did not receive any dietary supplements ( oral or injectable) in the past year(such as vitamin D3 and calcium) Serum levels of the vitamin D3 below 20 ng / ml The desire to participate in the study 18 years 65 years Both Pregnancy or breastfeeding comorbididty with other major psychological or neurological diseases such as bipolar disorder and multiple sclerosis Smoking and alcohol consumption History of compliance with certain diets Use of serum vitamin D suppressants (such as anticonvulsants and glucocorticoids) F20 Schizophrenia Treatment - Drugs Placebo Intervention group: Patients with schizophrenia who receive a dose of 2000 IU Vitamin D(Prepared by Dana Pharmaceuticals Inc.) per day(after lunch). Control group:Schizophrenic patients who are randomly assigned to the control group and will receive a placebo (provided by the Dana Pharmaceuticals Company) for 8 weeks. Components of metabolic syndrome including waist circumference, fasting blood glucose, HDL, triglyceride and blood pressure. Timepoint: Before the intervention and 8 weeks later. Method of measurement: Accordingly, the bandwidth (waist circumference), kit and autoanalyser (sugar, HDL and triglyceride) and mercury pressure gauge (blood pressure). Serum levels of glycogen synthase kinase 3, beta-catenin, BDNF, S100B and ZAG. Timepoint: Before the intervention and 8 weeks later. Method of measurement: ELISA. Tabriz University of Medical Sciences Approved 2019-03-12 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Nishabouri St., Tabriz, I. R. Iran. Tabriz East Azarbaijan Iran (Islamic Republic of)