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IRCT20200905048622N1 IRCT 2020-09-17 Esfahan University of Medical Sciences The effect of vitamin D deficiency treatment on lipid profile in ischemic heart diseases The effect of vitamin D deficiency treatment on lipid profile in ischemic heart diseases: a double blinded randomized clinical trial 2020-10-11 anticipated 66 Complete https://irct.ir/trial/50877 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients were allocated into intervention or control group using block randomization method to keep an even randomization ratio of (1:1). If the patient had inclusion criteria and did not excluded from the study according to above mentioned protocol, the random number generating software was used to determine their designated group. Numbers were between 0-9. If the number was even, the letter "A" was wrote at the top of their checklist by the examining physician, and if the number was odd, the letter "B" was used. Then, the next patient had to be assigned to the opposite group. This process repeated for the upcoming patients and continued until we reached our estimated sample size. After completing the study and before starting the data analysis process, the encrypted letters will be revealed by the pharmaceutical company, Blinding description: Double blinded including both participants and investigators. 3 Ischemic heart disease, Vitamin D deficiency. Intervention 1: Intervention group: getting oral vitamin D 50000 IU pearl weekly up to 2 months, zahravi pharmaceutical company. Intervention 2: Control group: getting oral Vitamin D placebo pearl with the same shape as the main drug made by Zahravi Pharmaceutical Company, once a week up to 2 months. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: starting 6 months after publication To whom: for people working in academic institutions Conditions: any analysis Where to obtain: email addresses How to obtain: After receiving the e-mail and determining the required data and analyzes on which the data is to be performed and with the consent of the project manager and research assistant The information is provided to the applicant. Comments:
public Masoumeh Sadeghi
Chamran heart hospital , Moshtagh 3 St.
Isfahan Iran (Islamic Republic of) 8158388994 +98 31 3611 5204 sadeghimasoumeh@gmail.com Esfahan University of Medical Sciences scientific Masoumeh Sadeghi
Chamran heart hospital , Moshtagh 3 St.
Isfahan Iran (Islamic Republic of) 8158388994 +98 31 3611 5204 sadeghimasoumeh@gmail.cim Esfahan University of Medical Sciences Iran (Islamic Republic of) Vitamin D level less than 30 ng/ml Ischemic heart disease : stable angina , acute coronary syndrome Age from 40 to 65 years 40 years 65 years Both Coronary artery bypass grafting (CABG) indications Any life threatening disease Any vitamin supplementation use Severe vitamin D deficiency ( < 10 ng / ml ) Treatment - Drugs Placebo Intervention group: getting oral vitamin D 50000 IU pearl weekly up to 2 months, zahravi pharmaceutical company Control group: getting oral Vitamin D placebo pearl with the same shape as the main drug made by Zahravi Pharmaceutical Company, once a week up to 2 months. Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), triglyceride, total cholesterol. Timepoint: before intervention and after 2 months (end of the study). Method of measurement: laboratory kit. Esfahan University of Medical Sciences Approved 2020-05-10 Ethics committee of isfahan university of medical sciences Ethics committee of isfahan university of medical sciences, Faculty of medicine, Hezarjarib St. Isfahan Isfehan Iran (Islamic Republic of)