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Effect of low caloric diet with and without vitamin D supplementation on trends of disease in non alcoholic fatty liver

Protocol summary

Summary
As a result of high prevalence of hypovitaminosis D in the nan alcoholic fatty liver patients we design a randomized double blind controlled trial in order to understand the relation of vitamin D with nonalcoholic fatty liver.at first and the end of the trail biochemical tests like (Fasting blood sugar, Total cholesterol, Triglyceride, AST, ALT, ALP, LDL,HDL, Bilirobin, OH-25 vitamin D, calcium, phosphor) and anthropometric parameters like (Weight, Height & Waist circumstance) will assess.also ultra sonography will assess at the beginning and in the end of the trial. Inclusion criteria: BMI>25 OH-25 vitamin D< 20 ngr/ml SGPT>40 mgr/dl a grade of fatty liver Exclusion criteria: liver disease kidney disease using spatial kind drug patients fulfilling criteria will be randomized to receive an intervention or to be in the control group. intervention group use low caloric diet and 50000 IU of vitamin D weekly and control group will use only low caloric diet. patients will follow up for 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091310826N1
Registration date: 2013-02-02, 1391/11/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-02, 1391/11/14
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoghi Medical University of Yazd
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low caloric diet with and without vitamin D supplementation on trends of disease in non alcoholic fatty liver
Public title
Effect of low caloric diet with and without vitamin D supplementation in non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between25 to65 years; Body mass index>=25; OH 25 Vitamin D<50 nmol/lit or 20 ng/ml; increase SGPT leve more than 40 mgr/dl; distinction of the grade of fatty liver by sconography and undrestanding by doctor. Exclusion criteria: liver disease like hepatitis; kidney disease; use low caloric diet or drugs for decrease weight in 6 month ago; lactation; gestation; use of steroid drugs; tamoxifen, prexilin, metotroxat, statin drugs; use of vitamin E & D 3 month ago; using alcoholic drinks; also patients that have weigh loss less than 5 percent of body or patients that without using 80 percent of vitamin D supplements will exclude from study.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science
Street address
Yazd, Imam Hosein Square
City
Yazd
Postal code
Approval date
2012-11-19, 1391/08/29
Ethics committee reference number
17/1/117118/پ

Health conditions studied

1

Description of health condition studied
non alcoholic fatty liver
ICD-10 code
k76.O
ICD-10 code description
Nonalcoholic fatty liver disease (NAFLD)

Primary outcomes

1

Description
SGPT
Timepoint
befor & after intervention
Method of measurement
mgr/dl, by blood sampling

2

Description
liver and bile duct supersonic graphy
Timepoint
before & after intervention
Method of measurement
radiologic picture

3

Description
OH 25 vitamin D
Timepoint
before & after intervention
Method of measurement
ngr/dl, blood sample

4

Description
BMI
Timepoint
before & after intervention
Method of measurement
kgr/m2,

Secondary outcomes

1

Description
waist circumfrence
Timepoint
before & after intervention
Method of measurement
cm,meter

2

Description
SGOT
Timepoint
before & after intervention
Method of measurement
mgr/dl,blood sample

3

Description
billirobin
Timepoint
before & after intervention
Method of measurement
mgr/dl,blood sample

4

Description
Alkalin phosphat
Timepoint
before & after intervention
Method of measurement
IU, blood samlpe

5

Description
Calcium
Timepoint
before & after intervention
Method of measurement
mgr/dl,blood sample

6

Description
Phosphour
Timepoint
before & after intervention
Method of measurement
mgr/dl, blood sample

7

Description
Fasting Blood Sugar
Timepoint
before & after intervention
Method of measurement
mgr/dl

8

Description
Triglycerid
Timepoint
Before & after intervention
Method of measurement
mgr/dl,blood sample

9

Description
Total cholestrol
Timepoint
before & after intervention
Method of measurement
mgr/dl,blood sample

10

Description
HDL
Timepoint
before & after intervention
Method of measurement
mgr/dl,blood sample

11

Description
LDL cholestrol
Timepoint
before & after intervention
Method of measurement
mgr/dl,blood sample

12

Description
weight
Timepoint
before & after intervention
Method of measurement
digital scale

13

Description
height
Timepoint
before & after intervention
Method of measurement
stadiometer,m

Intervention groups

1

Description
intervention group: using low caloric diet (kilo caloric/ body weight) - 500. 20% protein, 52% carbohydrate, 28% fat.also they use 50000 IU vitamin D weekly for 3 month.
Category
Treatment - Drugs

2

Description
control group: using low caloric diet (kilo caloric/ body weight) - 500. 20% protein, 52% carbohydrate, 28% fat.also they use placebo of vitamin D weekly for 3 month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
ARA Health clinic
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research services of shahid sadoughi university
Full name of responsible person
Dr. Hassan Mozafari
Street address
Yazd,bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research services of shahid sadoughi university
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of nutrition, School of public health, Shahid Sadoughi University
Full name of responsible person
Azade Najarzadeh
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Yazd, Imam hosein square
City
Yazd
Postal code
Phone
+98 35 1624 0696
Fax
Email
azadnajarzadeh@ssu.ac.ir; azmm1383@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University
Full name of responsible person
Narges Jani
Position
Msc student, Department of nutrition, School of public health, Shahid Sadoughi University
Other areas of specialty/work
Street address
Shahid Sadoughi University
City
Yazd
Postal code
Phone
+98 31 1661 7342
Fax
Email
narges_jani@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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