Protocol summary
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Study aim
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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
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Design
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Two arm parallel group double-blind randomised trial with concealed randomization
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Patients with non-alcoholic fatty liver disease (NAFLD) receiving calcitriol or placebo following random allocation
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Main outcome variables
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Serum levels of liver enzymes; levels of hepatic steatosis
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2017-06-28, 1396/04/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Ahvaz Jundishapur University of Medical Sciences
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Expected recruitment start date
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2017-09-23, 1396/07/01
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Expected recruitment end date
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2018-06-22, 1397/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Calcitriol supplementation in Nonalcoholic Fatty Liver Disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization with blocks of size 6 and random allocation to the blocks and allocation concealment was carried out using A and B codes
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-23, 1396/03/02
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Ethics committee reference number
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IR.AJUMS.REC.1396.161
Health conditions studied
1
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Description of health condition studied
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Non-Alcoholic Fatty Liver disease (NAFLD)
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Liver enzymes
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Timepoint
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Before and after 16 weeks calcitriol treatment
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Method of measurement
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Activity assay of enzymes in serum
Secondary outcomes
1
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Description
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Hepatic Steatosis
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Timepoint
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Before and after 16 weeks of calcitriol treatment
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Method of measurement
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Fibroscan elastography and enzymatic assay of glyceamic and lipid parameters in serum
2
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Description
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High sensitive C-reactive protein (hs-CRP)
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Timepoint
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Before and after 16 weeks of calcitriol treatment
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Method of measurement
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Enzyme-linked immunosorbent assay
3
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Description
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Total adiponectin
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Timepoint
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Before and after 16 weeks of calcitriol treatment
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Method of measurement
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Enzyme-linked immunosorbent assay
4
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Description
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Serum leptin
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Timepoint
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Before and after 16 weeks of calcitriol treatment
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Method of measurement
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Enzyme-linked immunosorbent assay
5
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Description
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Glycemic profile
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Timepoint
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Before and after 16 weeks of calcitriol treatment
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Method of measurement
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By measuring fasting serum glucose and insulin
6
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Description
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Lipid profile
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Timepoint
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Before and after 16 weeks of calcitriol treatment
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Method of measurement
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By enzymatic measurement of fasting serum triglyceride, cholesterol, HDL and LDL
Intervention groups
1
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Description
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0.25 µg/day calcitriol for 16 weeks
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Category
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Treatment - Drugs
2
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Description
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Calcitriol placebo
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz Jundishapur University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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SPSS files of results
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When the data will become available and for how long
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6 months after publication of results
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To whom data/document is available
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For academic staff
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Under which criteria data/document could be used
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Further analysis only with permission
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From where data/document is obtainable
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Dr. Hamid Yaghooti who is in charge of scientific inquiries should be contacted via email.
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What processes are involved for a request to access data/document
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Applications will be replied within 2 weeks following the required assessments.
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Comments
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