The effect of vitamin D3 supplementation on glycemic indices lipid profile and liver enzymes in cirrhotic patients
Design
Two Parallel group randomized Clinical Trial; double blinded
Settings and conduct
The aim of this study is to determine the effect of vitamin D supplementation on glycemic indices, lipid profile and liver enzymes in cirrhotic patients referring to Baqiyatallah Hospital. It is a double blind clinical trial . Sixty cirrhotic patients assigned randomly into two groups: 1- Vitamin D supplementation(50000 IU/ week for 12 weeks) ( intervention group) and 2- placebo ( control group ). Before and after the intervention, weight, BMI, FBS, HbA1C, insulin, insulin resistance, serum 25OHD, cholesterol, TG, HDL, LDL, ALT and ALT will be measured.
Participants/Inclusion and exclusion criteria
Both Males and females
age between 18 to 70 yrs
Confirmed cirrhosis disease
Not taking vitamin D3 supplementation in last 3 months ago
Not drinking alcohol in last 3 months ago
Not having the history of gastroplasty and jajenostomy
Intervention groups
The cirrhotic patients
Main outcome variables
BMI
25 Hydroxy vitamin D3
FBS
Hb A1C
Insulin
Insulin resistance
Total cholesterol
Total triglyceride
LDL cholesterol
HDL cholesterol
AST
ALT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140502017522N2
Registration date:2018-11-14, 1397/08/23
Registration timing:prospective
Last update:2018-11-14, 1397/08/23
Update count:0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
Maryam Taghdir
Name of organization / entity
Baqiyatallah University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 5511
Email address
mtaghdir@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D3 supplementation on glycemic indices lipid profile and liver enzymes in cirrhotic patients
Public title
The effect of vitamin D3 supplementation on glycemic indices lipid profile and liver enzymes in cirrhotic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
cirrhotic patients
Exclusion criteria:
Taking vitamin D since Last 3 months
Pregnant women
lactating Women
Patient with a history of Gastroplastic or jejunostomic
vitamin D level higher than 50 ng/ml
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization;
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Hospital, Mollasadra Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2018-10-08, 1397/07/16
Ethics committee reference number
IR.BMSU.REC.1397.039
Health conditions studied
1
Description of health condition studied
Cirrhosis
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver
Primary outcomes
1
Description
Body mass index (BMI)
Timepoint
Two times: 1) before supplementation 2)After 12 weeks
Method of measurement
BMI compares weight to height, and is calculated by dividing weight (in kilograms) by height (in metres squared)
2
Description
25 hydroxy vitamin D3
Timepoint
Two times: 1) before supplementation 2)After 12 weeks
Method of measurement
Units are ng / ml using 25OHD ALIZA
3
Description
Fasting blood sugar (FBS)
Timepoint
Two times: 1) before supplementation 2)After 12 weeks
Method of measurement
Units are mg / dl using autoanalyzer
4
Description
HbA1c
Timepoint
Twoo times: 1) before supplementation 2)After 12 weeks
Method of measurement
Units are % using HbA1c kits
5
Description
Insulin
Timepoint
Two times: 1) before supplementation 2)After 12 weeks
Method of measurement
Units are μIU / ml using insulin kits
6
Description
Insulin Resistance
Timepoint
Two times: 1) before supplementation 2)After 12 weeks
Method of measurement
Using the index, HOMA-ir
7
Description
Cholesterol
Timepoint
Two times:1)Befor of supplementation 2)after 12 weeks
Method of measurement
In mg/dl and by autoanalyzer
8
Description
Triglycerides
Timepoint
Two times:1)Befor of supplementation 2)after 12 weeks
Method of measurement
In mg/dl and by autoanalyzer
9
Description
High Density Lipoprotein
Timepoint
Two times:1)Befor of supplementation 2)after 12 weeks
Method of measurement
In mg/dl and by autoanalyzer
10
Description
Low Density Lipoprotein
Timepoint
Two times:1)Befor of supplementation 2)after 12 weeks
Method of measurement
In mg/dl and by auto analyzer
11
Description
Aspartat Amino Teransferase (AST)
Timepoint
Two times:1)Befor of supplementation 2)after 12 weeks
Method of measurement
In unit per liter and by autoanalyzer
12
Description
ALanin Amino Teransferase (AST)
Timepoint
Two times:1)Befor of supplementation 2)after 12 weeks
Method of measurement
in Unit per liter and by Autoanalyser
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50000 IU Vitamin D weekly for 12 weeks