Purpose of the study: A single-blind, clinical trial, with block randomization design, investigating the effect of vitamin D supplementation on severity of cirrhosis based on CHILD and MELD scores in patients with decompensate cirrhosis.
Study population: All chronic liver patients with CHILD>000 and MELD>000 admitted to Imam Reza Hospital due to complications.
Inclusion criteria: All the decompensated cirrhosis patients (CHILD≥7) admitted to hospital or referred to Gastroenterology Clinics; aged more than 18 years; and consent to participate in the study.
Exclusion criteria: Human immunodeficiency virus patients; renal failure due to reasons other than liver failure; malabsorption such as chronic diarrhea, celiac, chronic pancreatitis; patients undergoing corticosteroid treatment; pregnancy; and cirrhosis patients secondary to cholestasis such as primary biliary cirrhosis.
Sample size: 80
Study intervention: 50000 units of vitamin D on a daily basis for three months.
The outcome of the study: Survey of liver function based on MELD scoring system according to levels of bilirubin and creatinine serum as well as Child-Pugh classification system that classifies the severity of liver diseases into five categories, results in the two groups will be compared with the initial values after three months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020326342N1
Registration date:2016-02-28, 1394/12/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Hossein Ali Abbasi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 3031
Email address
mozaffarih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-03-11, 1394/12/21
Expected recruitment end date
2017-03-11, 1395/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of vitamin D supplementation on severity of cirrhosis based on CHILD and MELD scores in patients with decompensate cirrhosis
Public title
Effectiveness of vitamin D supplementation on severity of chronic liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the decompensated cirrhosis patients (CHILD≥7) admitted to hospital or referred to Gastroenterology Clinics; aged more than 18 years; and consent to participate in the study.
Exclusion criteria: Human immunodeficiency virus patients; renal failure due to reasons other than liver failure; malabsorption such as chronic diarrhea, celiac, chronic pancreatitis; patients undergoing corticosteroid treatment; pregnancy; and cirrhosis patients secondary to cholestasis such as primary biliary cirrhosis
Age
From 18 years old to 139 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2015-08-21, 1394/05/30
Ethics committee reference number
IR.Mums.sm.REC.1394.276
Health conditions studied
1
Description of health condition studied
Chronic liver disease
ICD-10 code
K76.1
ICD-10 code description
Chronic passive congestion of liver
Primary outcomes
1
Description
Liver function
Timepoint
3 months after intervention
Method of measurement
MELD scoring system; according to levels of bilirubin and creatinine serum
Secondary outcomes
1
Description
Liver function
Timepoint
3 months after intervention
Method of measurement
Child-Pugh scoring system; classifies the severity of liver diseases into five categories
Intervention groups
1
Description
Control group: popular drugs using for liver cirrhosis
Category
Treatment - Drugs
2
Description
Intervention group: popular drugs using for liver cirrhosis and 50000 units of vitamin D on a daily basis for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Hossein Ali Abbasi
Street address
Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Ali Abbasi
Position
Gastroenterologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3859 1057
Fax
Email
hoseinabbasi1342@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Homan Mozafari
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
MozaffariH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Ali Abbasi
Position
Gastroenterologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Emam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3859 1057
Fax
Email
hoseinabbasi1342@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)