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IRCT20220506054753N1 IRCT 2024-01-31 Tabriz University of Medical Sciences Investigating the effect of vitamin D on discoid lupus erythematosus The effectiveness of vitamin D injection compared to placebo on disease severity in patients with discoid lupus erythematosus 2022-09-23 anticipated 30 Complete https://irct.ir/trial/63521 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by using a table of individual and single-layer random numbers, which is prepared by computers that arrange numbers randomly. Concealed allocation will be done using a central service that is not aware of the research, Blinding description: All participants in this study will receive standard treatment for the disease, and randomly half of the patients will receive vitamin D and half placebo in addition to standard treatment. The participants' clinical caregiver, who monitors and evaluates the severity of the disease, is not aware of the patient receiving or not receiving vitamin D and will be kept blind before and after treatment and during the study process to avoid any prejudice. The appearance of the drug under study and a similar placebo will be selected. 3 Discoid lupus erythematosus. Intervention 1: Intervention group: taking oral vitamin D3 1000 tablets once a day for 3 months produced by Abidi factory. Intervention 2: Control group: taking placebo once a day for 3 months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: To perform meta-analysis Where to obtain: Bahareh Mehramuz bmehramuz@yahoo.com How to obtain: Sending email and explaining the reasons to bmehramuz@yahoo.com Comments:
public Bahareh Mehramuz
Imam Reza hospital, Golgasht street, Daneshgah street
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3337 3901 mehramuzb@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Bahareh Mehramuz
Imam Reza hospital, Golgasht street, Daneshgah street
Tabriz Iran (Islamic Republic of) 5163639888 +98 41 3337 3901 mehramuzb@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Aged over 18 years Patients with DLE whose initial diagnosis based on clinical manifestations was confirmed during a histopathological study of a skin sample sent to the pathology department Referred to the dermatology clinic of Sina Hospital in Tabriz Providing Informed consent 18 years no limit Both Systemic lupus erythematosus Active kidney disease Hepatitis Malabsorption syndrome Corticosteroid, dietary supplements and contraceptives, or anticonvulsants (phenytoin and phenobarbital) users People with liver enzymes over 40 Abnormal sensitivity to vitamin D Pregnant women L93.0 Discoid lupus erythematosus Treatment - Drugs Placebo Intervention group: taking oral vitamin D3 1000 tablets once a day for 3 months produced by Abidi factory Control group: taking placebo once a day for 3 months The severity of discoid lupus erythematosus using CLAS criteria. Timepoint: Measurements before starting treatment and after 3 months of oral vitamin D treatment. Method of measurement: Cutaneous LE Disease Area and Severity Index (CLAS) criteria. Vitamin D levels. Timepoint: Before and after the treatment period 3 months. Method of measurement: Individuals will undergo venous blood draw from the Antecubital area after 14-14 hours of fasting. The obtained samples will be measured by vitamin D level by quantitative luminescence method. Tabriz University of Medical Sciences Approved 2022-08-03 Ethics committee of Tabriz University of Medical Sciences Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)