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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

Protocol summary

Study aim
Our goal of this study is to know what effect the intervention has on hsCRP, ESR, lipid profile, blood sugar, appetite, fatigue, blood pressure, anthropometric indices, pulse rate and exercise test results in heart failure patients.
Design
The clinical trial has a control group and is factorial. This study is open label and has 120 patients. STATA version 16 software is used for randomization.
Settings and conduct
In this study, 120 people with heart failure will be divided into two intervention and control groups. The place where the study is conducted is in the Cardiac Rehabilitation Center and Clinic of Chamran Hospital, Isfahan. This study is open. The assessor, the laboratory and the epidemiologist were blinded to the method of intervention.
Participants/Inclusion and exclusion criteria
Entry requirements: willingness to cooperate with the project Age 40 to 65 years Patients with FH heart failure The ability to consume food properly Vitamin D levels less than 30 ng/ml، Conditions of non-entry: pregnancy, breastfeeding, hospitalization malignancy Use of dietary supplements Follow a special diet Chronic kidney disease Consumption of vitamin D supplements Patients who do not have normal levels of creatine and urea. In other words, people whose EF is less than 40.
Intervention groups
This study has four groups and 30 people have been allocated for each group. The first group receive vitamin D, the second group will receive DASH diet, and the third group will receive both interventions (vitamin D and DASH diet) at the same time. The fourth group (control) receives placebo .
Main outcome variables
Blood pressure, pulse rate, appetite, lipid profile, blood sugar, fatigue, exercise test, hsCRP,ESR,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171205037760N2
Registration date: 2023-08-08, 1402/05/17
Registration timing: prospective

Last update: 2023-08-08, 1402/05/17
Update count: 0
Registration date
2023-08-08, 1402/05/17
Registrant information
Name
ABBAS ABBASI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3424 9909
Email address
arvinabbasi55@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
More than 1 sample in each individual
Number of samples in each individual: 1
In this study, 120 people will be divided into intervention and control groups based on the specified sample size formula. 30 people in the first group will receive only vitamin D, and another 30 people in the second group will only receive the DASH diet, and another 30 people in the third group will receive both interventions (vitamin D and the DASH diet) at the same time, and the fourth group or control receives placebo control. The control group is also 30 people.
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Eefahan University of Medical Sciences
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73441
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.MUI.RESEARCH.REC.1402.168

Health conditions studied

1

Description of health condition studied
HEART FAILURE
ICD-10 code
I50.33
ICD-10 code description
Acute on chronic diastolic (congestive) heart failure

Primary outcomes

1

Description
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.

2

Description
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.

3

Description
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 .

4

Description
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

5

Description
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

6

Description
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

7

Description
Appetite is desire for food.
Timepoint
At the beginning of the study and two months after the intervention
Method of measurement
Questionnaire

8

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Rehabilitation

3

Description
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.
Category
Rehabilitation

4

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Masomeh Sadeghi
Street address
Dr. Chamran Shahid Heart Hospital, after Shahristan Bridge, Salman Farsi St.
City
Esfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 31 3303 3710
Email
arvinabbasi2040@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Heydari
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
73461-81746.
Phone
+98 31 3668 0048
Email
arvinabbasi2040@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masomeh Sadeghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Isfahan University of Medical Sciences, Isfahan School of Medical Sciences, Thousand Jarib Street
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sadeghimasoumeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Safavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Faculty of Nutrition
City
Esfahan
Province
Isfehan
Postal code
81746-73441
Phone
009 09131181981
Email
safavimorteza@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Morteza Safavi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences, Faculty of Nutrition,
City
Esfahan
Province
Isfehan
Postal code
81746-73441
Phone
+98 913 118 1981
Email
safavimorteza@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Laboratory results and clinical evaluations can be shared
When the data will become available and for how long
Access 6 months after results are printed
To whom data/document is available
Accessibility for academics
Under which criteria data/document could be used
They are only allowed to study
From where data/document is obtainable
researcher
What processes are involved for a request to access data/document
The application must be submitted through a scientific center to Isfahan University of Medical Sciences, Faculty of Nutrition
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