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IRCT20171205037760N2 IRCT 2023-08-08 Esfahan University of Medical Sciences Association the combined and separate effects of the DASH diet and vitamin D supplementation on inflammatory markers and improvement of heart condition in patients with heart failure Association the combined and separate effects of the DASH diet and vitamin D supplementation on inflammatory markers and improvement of heart condition in patients with heart failure 2023-09-01 anticipated 120 Complete https://irct.ir/trial/71762 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: In this study, to allocate people in the intervention and control groups, we use the block method and we use the eight block method, and according to this blocking, the chance of assigning people to each of the four groups will be the same. . Our sample size is 120 people, 90 people will be in the intervention group and 30 people will be in the control group. Random allocation method is block classification using Stata software version 16. Blocking will be done by an epidemiologist. 3 HEART FAILURE. Intervention 1: In intervention 1, 30 patients received only vitamin D. The intake of vitamin D is once a week and its duration is for two months. The supplement is given to the patients by the researcher. The supplement will be provided by Dana Pharmaceutical Company, which is available in the food supplement market under the name of vitamin D3 under the brand name D Vigil and is approved by relevant organizations. Intervention 2: Intervention group 2: In this group, which is about 30 people, they receive DASH diet advice. This diet is based on the consumption of vegetables, fruits, low-fat dairy products and nuts. In this diet, the consumption of red meat, sweets and solid oil is reduced. Intervention 3: Intervention group 3: In this group, which has 30 people, they receive vitamin D and DASH diet at the same time. They receive vitamin D 50,000 every week for a period of two months. The supplement will be provided by Dana Pharmaceuticals, which is available in the nutritional supplement market under the name vitamin D3 under the brand name D Vigil, and the group will also receive DASH diet recommendations based on calorie needs. Intervention 4: Control group, which has 30 people, they receive placebo vitamin D. Placebo contains gel and is given to patients once a week for two months. This group of patients does not receive the DASH diet. Yes - There is a plan to make this available What will be shared: Laboratory results and clinical evaluations can be shared When: Access 6 months after results are printed To whom: Accessibility for academics Conditions: They are only allowed to study Where to obtain: researcher How to obtain: The application must be submitted through a scientific center to Isfahan University of Medical Sciences, Faculty of Nutrition Comments:
public Masomeh Sadeghi
Isfahan University of Medical Sciences, Isfahan School of Medical Sciences, Thousand Jarib Street
Esfahan Iran (Islamic Republic of) 7346181746 +98 31 3668 0048 sadeghimasoumeh@gmail.com Esfahan University of Medical Sciences scientific Morteza Safavi
Isfahan University of Medical Sciences, Faculty of Nutrition
Esfahan Iran (Islamic Republic of) 81746-73441 009 09131181981 safavimorteza@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate with the plan 40 to 65 years old Patients with stage 1 of heart failure. In other words, patients with an %EF between 40 and 50 are included in the study. The ability to consume food properly (in other words, those patients will be selected who have the ability to consume vegetables and fruits, for example, have teeth suitable for chewing, are not hospitalized, have the ability and ability to prepare food, and or someone prepares it for them) Vitamin D levels less than 30 ng/ml 40 years 65 years Both Pregnancy, breastfeeding, hospitalization and Malignancy Use of nutritional supplements in the last 3 months Following a special diet• Chronic kidney disease Consumption of vitamin D supplements in the last three months. Patients who do not have normal levels of creatine and urea People with moderate and severe %EF. In other words, people whose %EF is less than 40 I50.33 Acute on chronic diastolic (congestive) heart failure Rehabilitation Rehabilitation Rehabilitation Rehabilitation In intervention 1, 30 patients received only vitamin D. The intake of vitamin D is once a week and its duration is for two months. The supplement is given to the patients by the researcher. The supplement will be provided by Dana Pharmaceutical Company, which is available in the food supplement market under the name of vitamin D3 under the brand name D Vigil and is approved by relevant organizations. Intervention group 2: In this group, which is about 30 people, they receive DASH diet advice. This diet is based on the consumption of vegetables, fruits, low-fat dairy products and nuts. In this diet, the consumption of red meat, sweets and solid oil is reduced. Intervention group 3: In this group, which has 30 people, they receive vitamin D and DASH diet at the same time. They receive vitamin D 50,000 every week for a period of two months. The supplement will be provided by Dana Pharmaceuticals, which is available in the nutritional supplement market under the name vitamin D3 under the brand name D Vigil, and the group will also receive DASH diet recommendations based on calorie needs. Control group, which has 30 people, they receive placebo vitamin D. Placebo contains gel and is given to patients once a week for two months. This group of patients does not receive the DASH diet. HsCRP: One of the heart risk markers used to help determine a person's risk. It will be measured using immunoturbidometry. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: laboratory measurements, It is measured by immunoturbidometry. ESR: erythrocyte sedimentation rate (ESR); It is an indirect measure of the degree of inflammation in the body. This test measures the sedimentation rate of red blood cells in a blood sample placed in a long, narrow, vertical tube. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: A long, narrow and vertical pipe is used for measuring. The result of the ESR test is recorded in millimeters and the duration of red blood cell sedimentation is considered. The normal level of this test is 0-29 for women and 0-22 for men. Assessment of malnutrition:Check possible malnutrition in patients during treatment. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: It is measured through Mini nutritional assessment questionnaire . What is blood pressure: Normal blood pressure is a vital function of the body. Blood pressure is the force that propels blood through our circulatory system, bringing oxygen or nutrients to tissues and organs through arteries. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: blood pressure monitor. Blood fat test or lipid profile is a combination of tests that are considered to check the risks of coronary heart disease and include markers (LDL, HDL, TRIGLYCERIDE, TOTAL CHOLESTEROL) or as a preventive measure to check risks related to factors such as: Eating habits, diet, stress, exercise and lifestyle are done. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: through laboratory kits for measuring LDL, HDL, THREE TRIGLYCERIDE, TOTAL CHOLESTEROL. Glucose reaches the body through food. After digesting carbohydrates, the body turns them into sugar that circulates in the blood. Blood sugar is necessary for the body to receive energy and is the so-called source of body energy. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: Blood glucose kit. Appetite is desire for food. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: Questionnaire. Cardiac exercise test is one of the necessary tests to check the heart's performance in active mode. The cardiologist requests this test to check the possibility of heart diseases in the patient. This test is one of the body checkup tests for people with heart problems. In this test, the patient usually walks on a regular treadmill according to the Bruce protocol or a similar exercise program, until the heart rate reaches the expected level or certain symptoms appear in the person. The process of performing this test is that heart function and blood pressure are checked in the exercise test, before, during and after the exercise test. These tests help the doctor to diagnose the problem. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: First, the pulse, blood pressure and heart rate are measured and then they are measured and recorded repeatedly during the test. After the heart examination, it will be placed on the treadmill for the exercise test. This device is a movable and rolling rubber plate (similar to a conveyor) on which the patient stands and must walk on it to maintain balance. Every 3 minutes, the slope of the strip will increase by 2% and its speed will increase by 1.2 km per hour. Esfahan University of Medical Sciences Approved 2023-07-31 Ethics committee of Eefahan University of Medical Sciences Hazar Jarib Street, Isfahan University of Medical Sciences Esfahan Isfehan Iran (Islamic Republic of)