The aim of the present study was to evaluate the effects of low dose zinc supplementation on the biochemical markers and underlying disease status in cirrhotic patients. Sixty cirrhotic patients were enrolled in the double-blind, placebo-controlled, randomized clinical trial study. The exclusion criteria were age less than 18 years, hepatocellular carcinoma, use of Aldacton or other diuretics over than 50 mg daily , use of anabolic hormones, diuretics or Alb (in recent one month), sever renal or respiratory disorders, pregnancy and lactation, Diabetes Mellitus, liver transplantation during the study period and also the patients with clinical evidence of ascites. All patients in the intervention group (n=30) received long term zinc supplementation (50 mg elemental zinc sulfate daily) and the others received placebo. The Child-Pugh score and biochemical markers were assessed for both intervention and control groups at the first day and the end of 90th day intervention period. A per-protocol analysis was performed after excluding all participants who did not receive or complete the randomized intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106122017N4
Registration date:2011-09-07, 1390/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-07, 1390/06/16
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2006-05-05, 1385/02/15
Expected recruitment end date
2006-11-06, 1385/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc supplementation on clinical situation and biochemical markers in cirrhosis
Public title
Zinc supplementation in cirrhotic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age more than 18 years and suffering from cirrhosis.
Exclusion criteria: hepato cellular carcinoma; use of Aldacton or other diuretics over than 50 mg daily; use of anabolic hormones; diuretics or Alb (in recent one month); sever renal or respiratory disorders; pregnancy and lactation; Diabetes mellitus; liver transplantation during the study period and patients with clinical evidence of ascites
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz University of Medical Science
Street address
vice-chancellor for reseach Tabriz University of Medical Science,gholghasht Ave.
City
Tabriz
Postal code
Approval date
2005-11-12, 1384/08/21
Ethics committee reference number
8544
Health conditions studied
1
Description of health condition studied
Chronic Liver Failure
ICD-10 code
K72.1
ICD-10 code description
Chronic hepatic failure
Primary outcomes
1
Description
Child-Pugh score
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
Numeral, calculates with severity of Ascitis, total bilirubin, INR, albumin , severity of Encephalopathy
2
Description
Serum Zinc level
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
µg/dl
3
Description
Copper level
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
µg/dl
4
Description
Iron level
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
µg/dl
5
Description
Albumin level
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
gr/dl
6
Description
BUN
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
mg/dl
7
Description
Creatinin
Timepoint
At the first day and the end of 90th day of interventional period
Method of measurement
mg/dl
Secondary outcomes
1
Description
Clinical and lab test
Timepoint
Three month after intervention
Method of measurement
Clinical and laboratory tests
Intervention groups
1
Description
Interventional group: Zinc Sulfate Capsule , 50 mg daily, oral for three months
Category
Treatment - Drugs
2
Description
The control group: starch coated Capsule, daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikhorrais speciality and subspeciality clinic
Full name of responsible person
Mohammad Hossein Somi, MD
Street address
Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Somi
Street address
Imam Reza Hospital, Gholghasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Liver and Gastrointestinal Diseases Research Center, Tabriz 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
Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Parisa Rezaeifar, MD
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, gholghasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1336 7473
Fax
Email
prezaeifar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Alirreza Ostad Rahimi, MD
Position
Assistant Professor of Nutrition
Other areas of specialty/work
Street address
Imam Reza Hospital, Gholghasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1336 7473
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Parisa Rezaeifar, MD
Position
resident of Internal medicine
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)