Effect of Calcitriol supplementation on the severity of fatty liver, inflammatory and metabolic biomarkers in patients with non-alcoholic fatty liver with different genotypes of vitamin D receptor
This study aimed to investigate the effect of calcitriol treatment on non-alcoholic fatty liver disease (NAFLD) patients with different genetic polymorphisms of vitamin D receptor. In a single center randomized double-blind placebo controlled trial; 160 participants aged between 18 and 60 years with hepatic steatosis are treated with Calcitriol (0.25 µg/day) for 16 weeks. Patients are randomized to receive calcitriol or placebo. Major inclusion criteria include: men and women aged between 18 and 60 years with presence of hepatic steatosis diagnosed by Fibroscan elastography and increased liver enzymes. Major exclusion criteria include: patients with chronic liver diseases, alcohol consumption, hypercalcemia and those receiving hepatotoxic drugs. Intervention: Calcitriol and placebo for 16 weeks. The primary outcome: improvement in serum ALT, AST, GGT. Secondary outcomes are improvement of hepatic steatosis and metabolic component of patients including fasting plasma glucose, LDL, HDL, triglyceride and total cholesterol
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053034222N1
Registration date:2017-06-28, 1396/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-06-28, 1396/04/07
Registrant information
Name
Hamid Yaghooti
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8430
Email address
yaghooti-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Calcitriol supplementation on the severity of fatty liver, inflammatory and metabolic biomarkers in patients with non-alcoholic fatty liver with different genotypes of vitamin D receptor
Public title
Calcitriol supplementation in Nonalcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18- 60 years; the presence of NAFLD diagnosed by Fibroscan elastography; increased alanine transaminase (> 40 U/L); BMI below 35.
Exclusion criteria: Alcohol consumption greater than 20 g per day; pregnancy; lactation; viral or autoimmune hepatitis; hereditary hemochromatosis; Wilson's disease; α1-antitripsin deficiency; malabsorption syndromes; consumption of hepatotoxic drugs; high doses of synthetic estrogens; a history of hypothyroidism and Cushing's syndrome; Serum calcium greater than 10.6 mg/dl; a history of kidney stones; renal failure; intake of vitamin D, vitamin E and calcium supplements during last 3 months.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.AJUMS.REC.1396.161
Health conditions studied
1
Description of health condition studied
Non-Alcoholic Fatty Liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver enzymes
Timepoint
Before and after 16 weeks calcitriol treatment
Method of measurement
Activity assay of enzymes in serum
Secondary outcomes
1
Description
Hepatic Steatosis, lipids and gyceamic status
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
Fibroscan elastography and enzymatic assay of glyceamic and lipid parameters in serum
Intervention groups
1
Description
0.25 µg/day calcitriol for 16 weeks
Category
Treatment - Drugs
2
Description
Calcitriol placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Bijan Helli
Street address
Golestan Blvd.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
The Vice-Chancellor for Research and Technology
Street address
Golestan Blvd.
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
Fatemeh Ganavati
Position
MSc candidate
Other areas of specialty/work
Street address
Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 910 603 0433
Fax
Email
f.ghanavati88@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hyperlipidemia research center, Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Hamid Yaghooti
Position
PhD of clinical biochemistry
Other areas of specialty/work
Street address
Golestan Blvd.
City
Ahvaz
Postal code
Phone
+98 61 3338 9617
Fax
Email
yaghooti-h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr, Hamid Yaghooti
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)