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IRCT20211117053087N1 IRCT 2022-02-19 Alborz University of Medical Sciences The effect of single oral dose vitamin D on left ventricular remodelling in patients with acute anterior left ventricular infarction referred to Shahid Rajaei Hospital and comparison with randomized clinical trial control group IRCT The effect of single oral dose vitamin D on left ventricular remodelling in patients with acute anterior left ventricular infarction referred to Shahid Rajaei Hospital and comparison with randomized clinical trial control group IRCTcular 2022-01-04 anticipated 140 Complete https://irct.ir/trial/60216 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by block randomization method with heterogeneous blocks 2, 4, and 6 to hide the allocation order. The randomization list will be prepared in advance using the software available on the relevant, reputable website. (https://www.sealedenvelope.com/simple-randomiser/v1/lists). After the physician (responsible researcher) determines that the patient is eligible, the researcher, who has the confidential randomization list, will be contacted to assign the patient to one of the two groups, Blinding description: Both the data analyzer and the sample collector are kept blind. These people do not know which study group the questionnaire they fill out with patients belongs to. Intervention or control. Analysts also analyze raw information in which it is not clear whether this information is for the control group or the intervention. 3 Patients with acute left ventricular anterior infarction who are candidates for angioplasty. Intervention 1: Intervention group: People in the intervention group are patients with acute anterior infarction of the left ventricle who are referred to Rajai Hospital in Karaj. If vitamin D is below 30 in the blood, they will be given a bolus dose of 50,000 units of vitamin D. And it is recommended to take one pill a week of vitamin D. Intervention 2: Control group: receives routine treatments that patients with acute anterior infarction receive and there is no change in the treatment process. 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 As a medical student, which is my dissertation, I leave the decision in this regard to the faculty and the research committee of the faculty.
public Fatemeh Basavand
Alborz Ubiversity of Medical Science
Karaj Iran (Islamic Republic of) 0000000 +98 919 772 3022 ffatemehhbsv@gmail.com Karaj University of Medical Sciences scientific Fatmeh Basavand
Alborz University of Medical Science/ West Bouali/Nabbovat Boulvard
Karaj Iran (Islamic Republic of) 0000 +98 26 3255 8921 ffatemehhbsv@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) age between 40_85 patients with Anterior infarction less than 12 hours after the onset of symptoms Patient informed consent to participate in the research project 40 years 85 years Both history of infarction history of abnormal LVEF history of cardiomyopathy History of taking vitamin D supplements Moderate to severe valvular disease Calcium above 10.5 Allergy to vitamin D supplementation Individuals with BMI above 30 m2 / kg People who are not expected to stay in the study People with any life-threatening medical conditions renal failure liver failure People with a history of any known cancer Rheumatological and immunological diseases Treatment - Drugs N/A Intervention group: People in the intervention group are patients with acute anterior infarction of the left ventricle who are referred to Rajai Hospital in Karaj. If vitamin D is below 30 in the blood, they will be given a bolus dose of 50,000 units of vitamin D. And it is recommended to take one pill a week of vitamin D. Control group: receives routine treatments that patients with acute anterior infarction receive and there is no change in the treatment process. LV EF. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. LVESDI. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. LVESVI. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. LVEDVI. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. LVEDDI. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. Diastolic function. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. LV MASS. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. Sphercity Index. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. GLS. Timepoint: At the beginning of the study and two months later. Method of measurement: ECO TDI. Troponin. Timepoint: At the beginning of the study and two months later. Method of measurement: Blood test. Alborz University of Medical Sciences Approved 2021-09-20 Ethics committee of Alborz University of Medical Science Sara Dormitory /The entrance of Honar pool/, Nabout Boulevard, /Karaj Karaj Alborz Iran (Islamic Republic of)