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The effect of vitamin D supplementation on serum hepatic enzymes, oxidative stress indicators & inflammatory markers in patients with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled trial

Protocol summary

Summary
The aim of study is evaluation of the effect of vitamin D supplementation on serum hepatic enzymes, oxidative stress indicators & inflammatory markers in patients with Non-Alcoholic Fatty Liver Disease Study design is double blind placebo controlled randomized clinical trial The study sample includes 60 patients (30 in intervention and 30 in control group) diagnosed with non alcoholic fatty liver disease of both gender Inclusion Criteria : diagnosis to have non alcoholic fatty liver disease ages above 18 and serum alanine transaminase enzyme level higher than normal (> 40 U/L). Exclusion criteria: Alcohol consumption greater than 20 g per day, pregnancy, lactation, having other hepatic diseases, using hepatotoxic drugs and consumption of vitamin D,vitamin E and calcium supplementation during last 6 months. Intervention: One pearl of vitamin D supplement contains 50000 IU vitamin D will be prescribed every other week for 4 months in intervention group. One placebo contains edible paraffin will be prescribed every other week for 4 months in control group. Primary Outcomes: Serum levels of hepatic enzymes include Alanine transaminase, Aspartate transaminase and alkaline phosphatase. Secondary Outcomes: Insulin resistance, Tumor necrosis factor α, Transforming growth factor β, hs-CRP, Adiponectin, Total antioxidant capacity, Malondialdehyde, Cytokeratin-18, Lipid profile, serum level of vitamin D.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012071810333N1
Registration date: 2012-11-14, 1391/08/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-11-14, 1391/08/24
Registrant information
Name
Nasrin Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 0608
Email address
sharifi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
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
The effect of vitamin D supplementation on serum hepatic enzymes, oxidative stress indicators & inflammatory markers in patients with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled trial
Public title
The effect of vitamin D supplementation in Non Alcoholic Fatty Liver Disease treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis to have non alcoholic fatty liver disease confirmed with sonography result, ages above 18 and serum alanine transaminase enzyme level higher than normal (> 40 U/L). Diabetic patients will include who have been recently diagnosed with diabetes and not using blood glucose lowering drugs or if they consume insulin and metformin, it would pass at least 6 months from starting the treatment and during this period the dose of metformin and insulin are not changed. Exclusion criteria: Alcohol consumption greater than 20 g per day, pregnancy, lactation, diseases such as hereditary hemochromatosis, Wilson's disease, an enzyme deficiency α1 Antitripsin, history of jejunoileal bypass surgery orgastroplasty, experience to perform the total parenteral nutrition at 6 months before, consomption of hepatotoxic drugs such as calcium channel blocker, high doses of synthetic estrogens, methotrexate, amiodarone, chloroquine, a history of hypothyroidism and Cushing's syndrome. Serum calcium greater than 10.6mg / dl , a history of kidney stones, renal failure, intake of vitamin D,vitamin E and calcium supplements during last 6 months.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Deputy of research and technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
ETH-605

Health conditions studied

1

Description of health condition studied
non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver

Primary outcomes

1

Description
Alanine Transaminase
Timepoint
Before and after intervention
Method of measurement
U/L - Laboratory kit

2

Description
Aspartate transaminase
Timepoint
Before and after intervention
Method of measurement
U/L - Laboratory kit

3

Description
Alkaline Phosphatase
Timepoint
before and after intervention
Method of measurement
U/L - laboratory kit

Secondary outcomes

1

Description
TNF-Alpha
Timepoint
Before and after intervention
Method of measurement
Pg/ml - Laboratory kit

2

Description
Insulin Resistance
Timepoint
Before and after intervention
Method of measurement
based on HOMA-IR

3

Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
Mg/L - Laboratory kit

4

Description
Transforming Growth Factor beta (TGF-b)
Timepoint
Before and after intervention
Method of measurement
Pg/ml- Laboratory kit

5

Description
Cytokeratin-18
Timepoint
Before and after intervention
Method of measurement
U/L - Laboratory kit

6

Description
Adiponectin
Timepoint
Before and after intervention
Method of measurement
microgram/ml - laboratory kit

7

Description
Malondialdehyde
Timepoint
Before and after intervention
Method of measurement
uM/L- laboratory kit

8

Description
Total antioxidant capacity
Timepoint
Before and after intervention
Method of measurement
mM Trolox equivalent- laboratory kit

9

Description
total cholesterol
Timepoint
Before and after intervention
Method of measurement
mg/dl - laboratory kit

10

Description
Triglyceride
Timepoint
Before and after intervention
Method of measurement
mg/dl- laboratory kit

11

Description
LDL-c
Timepoint
Before and after intervention
Method of measurement
mg/dl - laboratory kit

12

Description
HDL-c
Timepoint
Before and after intervention
Method of measurement
mg/dl- laboratory kit

13

Description
Serum Vitamin D
Timepoint
Before and after intervention
Method of measurement
ng/ml - laboratory Kit

Intervention groups

1

Description
Intervention: One pearl of Vitamin D ( 50000 IU) every other week for 4 months.
Category
Treatment - Drugs

2

Description
Control: Placebo with similarity in physical properties to Vitamin D pearl contains edible paraffin will be prescribed one every other week for 4 months
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Medical Clinic
Full name of responsible person
Dr. Eskandar Hajiani
Street address
Ghaem Medical Clinic, Taleghani Ave, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Abbaspour
Street address
Deputy of Research and Technology-Ahvaz Jundishapur University of Medical Sciences- Golestan Ave. - Ahvaz- Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Sharifi
Position
MSc/ PhD student of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Paramedical School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8317
Fax
Email
n_sharifi_nutr@yahoo.com - sharifi.n@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Reza Amani
Position
Associate professor of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, Paramedical School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
rezaamani@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Sharifi
Position
PhD student of Nutrition
Other areas of specialty/work
Street address
Department of Nutrition, paramedical School, Ahvaz Jundishapur University of Medical Sciences, Golestan Ave, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8319
Fax
Email
n_sharifi_nutr@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
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