Protocol summary

Study aim
The Effect of DASH Diet on Coagulation Factors, Liver Enzymes, Fibrosis and Steatosis Score and Metabolic Biomarkers in Children with Hemophilia
Design
Clinical trials with control groups, with parallel, randomized group, phase 2 on 40 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
People refer to the Hemophilia Patients Center in Isfahan province. These people are randomly divided into two groups of 20 people. DASH diet is part of the intervention diet Will be given 10 weeks. The control group was given a list of healthy nutrition recommendations. All variables will be measured before and after the intervention (10 weeks). The condition of the fatty liver will be checked using a fibroscan device. Evaluation of food intake by 3-day food recording as well as measurement of body composition by biomedical device will be performed at the beginning and end of the intervention for each person. Other indicators are measured using biochemical methods.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: 1. The desire to participate in the study 2. Male gender 3. Suffering from hemophilia (factor 7, 8 and 9 deficiency) 4. Age range between 10-18 years 5. Do not use antioxidant supplements for 3 months before the intervention 6. Do not use a special diet Criteria for not entering the study: 1- Non-compliance with the recommended diet 2- Having certain diseases during the study 3- Lack of desire to continue studying
Intervention groups
This study is divided into two groups: intervention and control. People in the intervention group receive DASH diet for 10 weeks, and people in the control group receive healthy food recommendations.
Main outcome variables
Prothrombin; ALT, AST; liver fibrosis and stenosis; FBS; lipid profiles; CBC; anthropometric indicators; SBP,DBP; weight and height; waist circumference; CRP; interleukin 6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130903014551N6
Registration date: 2020-05-26, 1399/03/06
Registration timing: prospective

Last update: 2020-05-26, 1399/03/06
Update count: 0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-08-09, 1399/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of DASH Diet on Coagulation Factors, Liver Enzymes, Fibrosis and Steatosis Score and Metabolic Biomarkers in Children with Hemophilia
Public title
The Effect of DASH Diet on Coagulation Factors, Liver Enzymes, Fibrosis and Steatosis Score and Metabolic Biomarkers in Children with Hemophilia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Male gender Suffering from hemophilia Age ranges between 10-18 years Do not use antioxidant supplements for 3 months before the intervention Do not use a special diet
Exclusion criteria:
Smoking and alcohol consumption Use of antihypertensive drugs, blood sugar and blood lipids Having liver, heart and kidney diseases
Age
From 10 years old to 18 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized permuted block (with block size 4) will generated by an independent bio-statistician. Random assignment will done by the use of table of random numbers. The enrolling participants, and assigning participants to the groups will carried out by a trained nutritionist.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Vice Chancellor for Research and Technology
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, Building No. 4 - Vice Chancellor for Research and Technology
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.098

Health conditions studied

1

Description of health condition studied
Hemophilia patient
ICD-10 code
D68.311
ICD-10 code description
Acquired hemophilia

Primary outcomes

1

Description
Prothrombin test
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

2

Description
ALT وAST
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

3

Description
Degree of liver fibrosis and steatosis
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Fibrosaccan device

4

Description
Fasting blood sugar
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

5

Description
Lipid profiles
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

6

Description
Complete blood count
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

7

Description
anthropometric measurements
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Body analysis machine

8

Description
Systolic and diastolic blood pressure
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Sphygmomanometer

9

Description
Weightand height
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Digital scales and tape measure

10

Description
waist circumference
Timepoint
Before and 10 weeks after the intervention
Method of measurement
tape measure

11

Description
hs-CRP
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

12

Description
Interleukin 6
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

Secondary outcomes

1

Description
Vitamin C
Timepoint
Before and 10 weeks after the intervention
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: Get a DASH diet in the form of diet plans written for 10 weeks and explain the program and replacement list for patients for 3 training sessions, get food record one before the intervention, one in 5 weeks and one after Intervention, examination of blood factors and liver enzymes before and after the intervention, examination of the degree of fibrosis and hepatic steatosis using the fibroscan device before and after the intervention.
Category
Prevention

2

Description
Control group: Only healthy dietary recommendations are taken during 10 weeks with a training session, taking a food record one before the intervention, one in the 5th week and one after the intervention, checking blood factors and liver enzymes before and after the intervention, checking the degree of fibrosis and liver steatosis using a fibroscan device before and after the intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for hemophilia patients in Isfahan province
Full name of responsible person
Dr. Maliheh Afzali
Street address
No, 33, 7 East Bostan, Imam Jafar Sadegh Alley, Hezar Jerib street, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174656511
Phone
+98 31 3235 4343
Email
infohemofilia1377@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
NO 33, 7East Bostan, Imam Jafar Sadegh Alley, Hezar Jerib street, Esfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
8174656511
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
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
Atena Mahdavi
Position
Executor of plan
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
NO 33, 7 East Bostan, Imam Jafar Sadegh Alley, Hezar Jerib, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174656511
Phone
+98 31 3673 4658
Email
atena.mahdavi2011@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamad Hossein Rohani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
NO 33, 7 East Bostan, Imam Jafar Sadegh Alley, Hezar Jerib street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174656511
Phone
+98 31 3792 3183
Fax
+98 31 1668 2509
Email
s_m_rouhani2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atena Mahdavi
Position
Executor of plan
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
NO 33, 7 East Bostan, Imam Jafar Sadegh Alley, Hezar Jerib street, Esfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8174656511
Phone
+98 31 3673 4658
Email
atena.mahdavi2011@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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