The effect of a single dose of vitamin D3 injection on serum 25 hydroxy vitamin D and adiponectin and liver function in women with non-alcoholic fatty liver disease
This randomized controlled clinical trial will be performed on 72 patients with NAFLD confirmed by sonographic image, and vitamin D deficiency.at baseline, demographic and physical activity questionnaires , and 24-hour dietary recall will be completed for each of the participants and anthropometric indices will be measured.Blood samples will be taken after 12 to 14 hours of fasting for measuring the level of liver enzymes and serum adiponectin and 25-hydroxyvitamin D.patients will be randomly divided into 2 intervention and control groups. both of them will receive 1 capsule of vitamin E(400 IU) daily for one month and in the intervention group, patients will be received vitamin D at a dose of 600,000 IU. The anthropometric and biochemical measurements and Sonography of the liver will be repeated at the end of study .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503163320N10
Registration date:2015-07-02, 1394/04/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-02, 1394/04/11
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-05, 1394/01/16
Expected recruitment end date
2015-09-07, 1394/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a single dose of vitamin D3 injection on serum 25 hydroxy vitamin D and adiponectin and liver function in women with non-alcoholic fatty liver disease
Public title
vitamin D and non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in the study, 18-50 years old, liver steatosis on sonographic image, vitamin D deficiency(25(OH)D levels less than 30ng/ml), BMI≥25
Exclusion criteria: Alcohol consumption(more than 20g/day), menopause, gestation or lactation, BMI>40, diabetes and insulin resistance, any other liver disease(viral disease, Wilson, Hemochromatosis, glycogen storage disorders and etc) or using drugs for the treatment of fatty liver(such as omega-3 and herbal supplements), Thyroid and parathyroid disorders, bone problems, Cushing's syndrome, fat malabsorption, cholecystectomy and any other disease that affect the liver, renal disease(renal failure and nephrolithiasis), using vitamin D, calcium and vitamin E supplements in the past 6 months, taking any drugs causing fatty liver or hepatotoxic drugs(calcium channel blocker,methotrexate,tamoxifen, valproate, diltiazem, amiodarone, isoniazid, corticosteroids and high-dose of estrogen and progestin, and the use of contraceptives), taking drugs affecting insulin resistance and liver function(Such as metformin, pioglitazone, lovastatin and etc.), get weight loss diet in the past 6 months, using total parenteral nutrition in the past 6 months.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street,Tabriz
City
Tabriz
Postal code
5166616471
Approval date
2015-05-04, 1394/02/14
Ethics committee reference number
TBZMED.REC.1394.63
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, not elsewhere classified
Primary outcomes
1
Description
serum 25(OH)D
Timepoint
Beginning and end of the intervention
Method of measurement
ELIZA
2
Description
serum Adiponectin
Timepoint
Beginning and end of the intervention
Method of measurement
ELIZA
3
Description
Liver Enzyme (ALT,AST,ALP)
Timepoint
Beginning and end of the intervention
Method of measurement
IFCC
4
Description
Liver steatosis
Timepoint
Beginning and end of the intervention
Method of measurement
Liver Sonography
Secondary outcomes
1
Description
anthropometry
Timepoint
Begining and end of intervention
Method of measurement
Scale and meter and bioelectrical impedance analyzer
2
Description
Energy and nutrient intake
Timepoint
Beginning and end of the intervention
Method of measurement
24- hour dietary recall
3
Description
Physical activity
Timepoint
Begining and end of intervention
Method of measurement
Physical activity Questionnaire
4
Description
sun exposure
Timepoint
Begining and end of intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
control group: Vitamin E400, 1 capsule/day for one month
Category
Treatment - Drugs
2
Description
Intervention Group: injection of vitamin D at the dose of 600000 IU at the beginning of study and Vitamin E400, 1 capsule/day for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykholrais clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Azadi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tabriz 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
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Nutrition, PhD
Other areas of specialty/work
Street address
Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
tabriz
Postal code
Phone
+98 41 3334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Nutrition, PhD
Other areas of specialty/work
Street address
Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences, Nutrition faculty
Full name of responsible person
Sonia Mansourian Hosseini
Position
Master Science Student of Nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
5185657538
Phone
00
Fax
Email
smansourian_h@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)