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IRCT20190819044565N1 IRCT 2019-09-28 Oroumia University of Medical Sciences Evaluating the effect of vitamin D supplementation on different stages of blood pressure Evaluation of the effect of vitamin D supplementation on different stages of blood pressure in hypertension patients with level of vitamin D under 30ng/ml 2019-09-23 anticipated 116 Complete https://irct.ir/trial/41659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, using Stratified Block Randomization statistical software, Blinding description: The data analyzer is aware of study group information, coding individual names, and participants, clinical caregiver, researcher, outcome assessor in this study will be kept blind to assignment to study groups, and supplements and placebo It will be distributed by someone who is not in the study. 3 Hypertension. Intervention 1: Intervention group: Vitamin D at a dose of 50000 international units of six supplements, one supplement for week and then two supplements, one for monthly, by Zahravi Tabriz Company, total intervention 14 weeks. Intervention 2: Control group: Six placebo supplements one supplement for week and then two supplements, one for monthly, by Zahravi Tabriz Company, total study 14 weeks. 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 No more information
public Samira Faraji
Kowsar Dormitory, Urmia University of Medical Sciences, Sero highway, Urmia, Iran
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3275 4953 FarajiSamira2019@yahoo.com Oroumia University of Medical Sciences scientific Samira Faraji
Sero highway, Kowsar Dormitory, Urmia University of Medical Sciences, Urmia, Iran
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3275 4953 FarajiSamira2019@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age range 18 years and above Interested in attending a study that filled out an informed consent form Hypertensive patients with systolic blood pressure above 140 and diastolic blood pressure above 90 with identical conditions and approved by the cardiologist in the study Serum vitamin D levels less than 30 ng/dl People who use only the following four drugs to control their blood pressure1Angiotensin Inhibitors (Losartan, Captopril, Valsartan)2 Calcium channel blockers (amlodipine, diltiazem)3Inhibitors of beta-adrenergic receptors (ethnolol, metoprolol, bisoprolol (concur))4Diuretics (hydrochlorothiazide, triamterene) 18 years no limit Both Mental, emotional, cognitive disorders People under 18 years People with secondary hypertension Specific dietary restrictions Pregnant women Nonsteroidal anti-Inflammatory drugs or glucocorticoids Disease that requires chemotherapy or radiation Consumption of bisphosphonates, including alendronate, alendronate and rhizdronate Use of anticonvulsant drugs (including phenytoin, phenobarbital, primidone, carbamazepine, x carbazepine, valproic acid, clonazepam) Use of antihyperlipidemic diarrhea medications including cholestyramine Alcohol consumption Consumption of radioactive iodine or any radiation Oral or injectable corticosteroids (including prednisone, prednisilone, dexamethasone, triaxinolone, hydrocortisone or beta-metazone) Kidney diseases Calcium supplements Lactating women Coeliac disease Crohn's disease Ulcerative colitis Steatorrhea Biliary problems Potassium supplementation Magnesium Supplementation I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention group: Vitamin D at a dose of 50000 international units of six supplements, one supplement for week and then two supplements, one for monthly, by Zahravi Tabriz Company, total intervention 14 weeks Control group: Six placebo supplements one supplement for week and then two supplements, one for monthly, by Zahravi Tabriz Company, total study 14 weeks Stages of blood pressure. Timepoint: at baseline (before intervention) and end of study (after 14 weeks). Method of measurement: Ambulatory Blood Pressure Monitoring, millimeter mercury. Vitamin D from daily diet. Timepoint: At the beginning of the study (before the intervention) and at 6 and 10 weeks and at the end of the study (after 14 weeks). Method of measurement: Food Frequency Questionnaire. Duration of exposure to sunlight. Timepoint: At the beginning of the study (before the intervention) and at 6 and 10 weeks and at the end of the study (after 14 weeks). Method of measurement: Sun Exposure Questionnaire. The amount of physical activity. Timepoint: At the beginning of the study (before the intervention) and at 6 and 10 weeks and at the end of the study (after 14 weeks). Method of measurement: International Physical Activity Questionnaire. Weight. Timepoint: At the beginning of the study (before the intervention) and at 6 and 10 weeks and at the end of the study (after 14 weeks). Method of measurement: Weigh measuring scales with accuracy of 0.1 ± mg, kilogram. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and at 6 and 10 weeks and at the end of the study (after 14 weeks). Method of measurement: Meter 0.1 centimetre precision. Serum vitamin D levels. Timepoint: At the beginning of the study (before the intervention) and at the end of the study (after 14 weeks). Method of measurement: Enzymatic method with auto analysis, nano molar per liter. Oroumia University of Medical Sciences Approved 2019-08-26 Ethics committee of Urmia University of Medical Sciences Department of Nutrition, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)