Protocol summary

Summary
The objectives of this study was to determine the effects of diet on the quality of life of children with chronic liver disease is liver-specific. Simple random sampling from among those listed in the hospital HIS system Ghaem Mashhad is performed and then samples were assigned to two groups. The population of the clinical trial in children with chronic liver disease who were referred to the pediatric hospital Ghaem Mashhad last at least 6 months of disease, the lack of restrictions on the physical health, mental health and lack of restrictions ranging from age 2 to 18 years are. The demographic questionnaire, Peds QL 4.0, anthropometric studies are completed first. Blood samples were tested for albumin, prothrombin time, aspartate aminotransferase, alanine aminotransferase and bilirubin were taken. Both specialized and general nutritional guideline is developed by studying books and articles. Specialized guide guide researchers and the general guidelines for patient's guide (Be competent / and children). Then guide the patient in the form of a six-day work shop on the subjects taught. In the first two sessions, which were the subject of meetings liver disease, and its impact on both groups are fed. The third session only groups are present and prepared booklet about their diet in chronic liver disease received. And 4 other session workshop topics calculate the energy, carbohydrate, lipid calculation and calculation of protein, vitamins, and finally calculates the final practice session for the calculation of the booklet to receive daily regimens. workshop through face to face training, multimedia and practical work will be held. Workshops are held three days a week for two weeks. After the last workshop patients were followed for 12 weeks. Participants once a week during the first month and the second month in person every two weeks to assess adherence and physical examination by their investigator. RECALL 24-hour sessions are forms to be filled by competent care. The data is archived in the case of research. During this period, Telephone researcher is competent to provide care in the event of a problem or need guidance with their call. At the end of 12 weeks of study, re-tools mentioned above are completed. After collecting data in order to comply with ethical principles, 4 the next session of the workshop booklet and follow-up three months after it was administered to the control group. 1. nutritional modification program, to improve the quality of life of children with chronic liver disease. (2) nutritional modification program, children with chronic liver disease decreased prothrombin time. 3. nutritional modification program, children with chronic liver disease increased albumin. 4. nutritional modification program, total bilirubin and direct children with chronic liver disease reduced. 5. The nutritional modification program, children with chronic liver disease and liver enzymes decreased.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091424019N1
Registration date: 2016-01-30, 1394/11/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Zahra Namjou
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 073 3270
Email address
namjooz911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-06-10, 1393/03/20
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nutritional modification program on quality of life and liver-specific symptoms in children with chronic liver disease
Public title
Diet and children with chronic liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for children: 1. Children with liver disease who are at least 6 months old disease 2. Iranian citizenship is a lie Mashhad. 3. patients tend to have the company study. 4. phone calls possible. 5. Children with chronic liver disease have other physical limitations. 6. children with chronic liver disease, mental health is not restricted. 7. aged 2 to 18 years old. Exclusion criteria related to children: 1. there is no desire to continue cooperation. 2. children to be fed TPN. 3. Children need to have a feeding tube. Inclusion criteria for the appropriate care: 1. The desire to have the company study. 2. Help is at least the third degree. 3 phone calls possible. Exclusion criteria for the appropriate care: 1. Randashth workshop is willing to continue cooperating companies
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical SciencesوFaculty of Nursing and Midwifery
Street address
Faculty of Nursing and Midwifery
City
Mashhad
Postal code
Approval date
2014-05-07, 1393/02/17
Ethics committee reference number
922144

Health conditions studied

1

Description of health condition studied
Chronic Liver Disease
ICD-10 code
K76.9
ICD-10 code description
Liver disease, unspecified

Primary outcomes

1

Description
Quality of life
Timepoint
First and end of the study
Method of measurement
Questionnaire Peds ql 4.0

2

Description
Prothrombin time
Timepoint
First and end of the study
Method of measurement
Values obtained from tests of Biochemistry

3

Description
Albumin
Timepoint
First and end of the study
Method of measurement
Values obtained from tests of Biochemistry

4

Description
Bilirubin
Timepoint
First and end of the study
Method of measurement
Values obtained from tests of Biochemistry

5

Description
Aspartate aminotransferase
Timepoint
First and end of the study
Method of measurement
Values obtained from tests of blood

6

Description
Alanine amino transferase
Timepoint
First and end of the study
Method of measurement
Values obtained from tests of blood

Secondary outcomes

1

Description
Height
Timepoint
First and end of the study
Method of measurement
The value of the stadiometer

2

Description
Weight
Timepoint
First and end of the study
Method of measurement
The value of the bio-electrical impedance devices

3

Description
Body Mass Index
Timepoint
First and end of the study
Method of measurement
Body weight divided by the square of Height is achieved Index

Intervention groups

1

Description
Training was conducted in 6 sessions. In the first two sessions, which were the subject of meetings liver disease, and its impact on nutrition. 4 other meeting issues of energy consumption, carbohydrate, lipid calculation and calculation of protein, vitamins, and finally calculates the final practice session for the calculation of daily regimens, respectively
Category
Other

2

Description
Training was conducted over 2 sessions. Which were the subject of meetings liver disease, and its impact on nutrition
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Science and Technology of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
Third floor, Qureshi building, University Avenue, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Science and Technology of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
zahra namjou
Position
master degree
Other areas of specialty/work
Street address
Mashhad, Faculty of Nursing and Midwifery
City
Mashhad
Postal code
Phone
00
Fax
Email
z.namjou@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
akram rezaeian
Position
master degree
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
rezaeiana@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
zahra namjou
Position
master degree
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery,Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
z.namjou@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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