Objectives: This study aimed to investigate the effect of vitamin D treatment in in patients non -alcoholic fatty liver disease (NAFLD).
Design:In a single center randomized double-blind placebo controlled phase 1 trial; 91 participants aged between 20 and 75 years with hepatic steatosis diagnosed by ultrasound (US) are treated with vitamin D capsule (group1), Calcitriol (group 2) and placebo (group 3).
Setting and conduct: Patients are randomized to receive weekly 50000 vitamin D capsule (group1), daily 0.25 mg Calcitriol (group 2) and placebo (group 3) for 12 weeks
Participants including major inclusion criteria: men and women aged between 20 and 75 years with presence of hepatic steatosis diagnosed by ultrasound (US). patients with chronic liver diseases were excluded
Intervention: 50000 vitamin D capsule (group1), daily 0.25 mg Calcitriol (group 2) and placebo (group 3) for 12 weeks
Main outcomes: The primary outcome was changes in serum ALT, AST, GGT from baseline to 12 weeks. Secondary outcomes were improvement of metabolic component of patients including fasting plasma glucose, LDL, HDL, triglyceride and total cholesterol.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612077732N2
Registration date:2017-02-26, 1395/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-26, 1395/12/08
Registrant information
Name
Ahad Eshraghian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5600
Email address
eshragha@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vitamin D supplementation for the treatment of non alcoholic fatty liver disease: a randomized double blind placebo controlled trial
Public title
Vitamin D supplementation for the treatment of non alcoholic fatty liver disease: a randomized double blind placebo controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: men and women aged between 20 and 75 years
with presence of hepatic steatosis diagnosed by ultrasound (US)
Exclusion criteria: Patients with liver cirrhosis; patients with hepatitis B or hepatitis C; patients with alcohol consumption (> 10 gr/ day); patients with autoimmune hepatitis; Wilson’s disease and hemochromatosis; known cancer; nephrolithiasis; nephrocalcinosis; chronic renal failure; hypercalcemia; hypercalciurea; pregnancy; lactation; patients receiving estrogen; tamoxifen; methotrexate; amiodarone; tetracycline and those receiving vitamin D and calcium supplementations in previous 6 months.
Age
From 20 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
106
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
Ethics committee of Shiraz university of medical sciences
Street address
zand boulevard
City
SHIRAZ
Postal code
Approval date
2014-02-02, 1392/11/13
Ethics committee reference number
CT-P-9205587
Health conditions studied
1
Description of health condition studied
NON ALCOHOLIC FATTY LIVER DISEASE
ICD-10 code
K76.0
ICD-10 code description
Primary outcomes
1
Description
liver enzymes
Timepoint
begining of the study-3 months after
Method of measurement
biochemicl kit
Secondary outcomes
1
Description
lipid profile and plasma glucose
Timepoint
begining of the study- 3 months later
Method of measurement
Biochemical kit
Intervention groups
1
Description
Intervention group 1:50000 U vitamin D3 (cholecalciferol) pearl (Zahravi Pharmacutical Co) per week for 3 months
Category
Treatment - Drugs
2
Description
Intervention group 2 : Intervention group 2: 0.25 mg calcitriol (1,25 dihydroxycholecalciferol) pearl (Zahravi Pharmacutical Co) per day for 3 months.
Category
Treatment - Drugs
3
Description
Control group: Placebo capsule (Zahravi Pharmacutical Co) /one per week for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Dabbaghmanesh
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
5th floor- Research Tower-Namazi hospital-Shiraz-Iran
City
Shiraz
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, Shiraz 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
Eendocrinology and metabolism research center
Full name of responsible person
mohammad hossein dabaghmanesh
Position
Professor
Other areas of specialty/work
Street address
5th floor, Research tower, Namazi hospital, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1569
Fax
Email
dabbaghmanesh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Endocrinology and Metabolism Research center
Full name of responsible person
Mohamamd hossein Dabbaghmanesh
Position
Professor
Other areas of specialty/work
Street address
5th floor, Research tower, Namazi Hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3628 1569
Fax
Email
dabbaghmanesh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahad Eshraghian
Position
Gastroenterologist and hepatologist
Other areas of specialty/work
Street address
Gastroenterology and hepatology Research Center, Research Tower, Namazi Hospital, Zand Boulevard, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 36281442
Fax
Email
Eshraghiana@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)