View older revisions Content changed at 2018-03-11, 1396/12/20

Protocol summary

Study aim
Evaluation of the effects of calcitriol administration on clinical and laboratory parameters in Non-Alcoholic Fatty Liver patients with different genotypes of vitamin D receptor FOK-I polymorphisms
Design
Two arm parallel group double-blind randomised trial with concealed randomization
Settings and conduct
Patients with non-alcoholic fatty liver disease (NAFLD) are recruited from Ahvaz Golestan hospital according to the inclusion/exclusion criteria and receiving the intervention or placebo for 16 weeks following random concealed allocation to the two groups. Participants, healthcare providers (Physicians and nurses) who care for participants during the trial, data collectors, outcome assessors, statistical analyzers and manuscript writers who are involved in our study are blinded.
Participants/Inclusion and 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.
Intervention groups
Patients with non-alcoholic fatty liver disease (NAFLD) receiving calcitriol or placebo following random allocation
Main outcome variables
Serum levels of liver enzymes; levels of hepatic steatosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT2017053034222N1
Registration date: 2017-06-28, 1396/04/07
Registration timing: prospective

Last update: 2018-03-11, 1396/12/20
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
2017-09-23, 1396/07/01
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 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 hypothyroidism and Cushing's syndrome Serum calcium greater than 10.6 mg/dl history of kidney stones; renal failure intake of vitamin D, vitamin E and calcium supplements
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
Block randomization with blocks of size 6 and random allocation to the blocks and allocation concealment was carried out using A and B codes
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, healthcare providers (Physicians and nurses) who care for participants during the trial, data collectors, outcome assessors, statistical analyzers and manuscript writers who are involved in our study are blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
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
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
Fibroscan elastography and enzymatic assay of glyceamic and lipid parameters in serum

2

Description
High sensitive C-reactive protein (hs-CRP)
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
Enzyme-linked immunosorbent assay

3

Description
Total adiponectin
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
Enzyme-linked immunosorbent assay

4

Description
Serum leptin
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
Enzyme-linked immunosorbent assay

5

Description
Glycemic profile
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
By measuring fasting serum glucose and insulin

6

Description
Lipid profile
Timepoint
Before and after 16 weeks of calcitriol treatment
Method of measurement
By enzymatic measurement of fasting serum triglyceride, cholesterol, HDL and LDL

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
Saied Seyedian
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33118
Phone
+98 61 3374 3061
Email
hmdyaghooti@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7543
Email
hmdyaghooti@gmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Narges Mohammadtaghvaie
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Fax
Email
ntaghvaie@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Yaghooti
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Fax
Email
yaghooti-h@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Yaghooti
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Golestan Blvd., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8317
Fax
Email
yaghooti-h@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
SPSS files of results
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
For academic staff
Under which criteria data/document could be used
Further analysis only with permission
From where data/document is obtainable
Dr. Hamid Yaghooti who is in charge of scientific inquiries should be contacted via email.
What processes are involved for a request to access data/document
Applications will be replied within 2 weeks following the required assessments.
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