Effect of vitamin D supplementation on inflammatory markers, liver function, lipid profile, body composition, and sonographic findings in patients with NAFLD
Vitamin D is a fat-soluble molecule that is essential for calcium balance and bone. Prevalence of vitamin D deficiency in adults is about 5 to 30 percent. But this deficiency in patients with metabolic syndrome by about 75 percent. Nonalcoholic fatty liver pathological accumulation of fat in the liver in which there is no liver disease. The prevalence of the disease around the world is estimated at 10-35% in adults. Iran is estimated that 7% of children and 35 percent of adults are infected with non-alcoholic fatty liver Nonalcoholic fatty liver is one of the components of metabolic syndrome. Studies of serum vitamin D levels associated with fatty liver there. According to the studies on the effect of vitamin D supplementation in patients with NAFLD has been.The objective of this study was to determine the effect of vitamin D supplementation on the recovery and improve the fat accumulation in the liver after liver enzymes in individuals with liver disease is ultrasound. This would be a parallel trial in which patients initially diagnosed with non-alcoholic fatty liver gastroenterologist are enrolled.Patients with NAFLD are not intervening in terms of age, sex and BMI matched with the experimental group are. In all patients, serum levels of vitamin D and liver function will be investigated.Vitamin D supplementation in the intervention group and the control group is given a placebo intervention. After 10 weeks, subjects of vitamin D levels and NAFLD are investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060411763N8
Registration date:2013-09-12, 1392/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-12, 1392/06/21
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-06-20, 1391/03/31
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on inflammatory markers, liver function, lipid profile, body composition, and sonographic findings in patients with NAFLD
Public title
Effect of vitamin D supplementation on inflammatory markers, liver function, lipid profile, body composition, and sonographic findings in patients with NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were stable increases in AST and ALT greater than 50 U / L and metabolic syndrome, which includes waist circumference greater than 40 inches for men and greater than 35 inches for women, Triglycerides greater than or equal to 150 mg /dl, HDL less than 40 mg / dl for men and less than 50 mg/dl for women, Blood pressure greater than or equal to 85/135 mmHg, fasting blood glucose greater than or equal to 110 mg / dl. The participants in this study have not hepatitis C, B and Wilson disease and no history of chronic liver disease, a disease that affects the gallbladder and bile ducts. The absence of gestational, diabetes mellitus type 1 and 2, use of drugs affecting the levels of ALT (valproic acid, tamoxifen, HMG-COA reductase inhibitors, metformin, ACE 1 and ACER 1). They do not follow the diet and weight loss because weight loss effective vitamin d. Exclusion criteria included hospitalization, lack of cooperation in the study and with an acute illness.
Age
No age limit
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)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
isfahan university medical science
Street address
isfahan
City
isfahan
Postal code
8174673461
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
391214
Health conditions studied
1
Description of health condition studied
non alcohlic fatty liver disease
ICD-10 code
k76
ICD-10 code description
Other diseases of liver
Primary outcomes
1
Description
The severity of fatty liver using abdominal ultrasound at baseline and end of study
Timepoint
Baseline and 10 weeks after intervention
Method of measurement
ultrasound
2
Description
AST and ALT liver enzymes
Timepoint
Baseline and 10 weeks after intervention
Method of measurement
Blood tests
Secondary outcomes
1
Description
body composition
Timepoint
baseline and 10 weeks after intervention
Method of measurement
instrument body composition
2
Description
FBS
Timepoint
baseline and 10 weeks after intervention
Method of measurement
blood test
3
Description
lipid profile
Timepoint
baseline and 10 weeks after intervention
Method of measurement
blood test
4
Description
CRP
Timepoint
baseline and 10 weeks after intervention
Method of measurement
blood test
Intervention groups
1
Description
This randomized clinical trial will be conducted in parallel. The objective of this study is the low number of participants in this study, 60 patients with NAFLD are referred to the Medical Research Center for Gastroenterology.The consent of the individuals participating in the study will be made in the experimental group during the 10-week study, which included a week Pearl vitamin D supplements are vitamin D 50,000 IU receive.The control group during the 10 weeks, each week placebo in terms of shape, color is similar to vitamin D supplements. The study followed patients for vitamin D supplement use,Weekly basis with the individuals contacted by telephone and SMS reminders to be a supplement to these people. To assess the level of acceptance of 25-hydroxy vitamin D supplements Gyy the size of the trucks will be used to study
Category
Treatment - Drugs
2
Description
Palcebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic fatty liver
Full name of responsible person
mahdi forroughi
Street address
City
ifahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Food Security Research Center
Full name of responsible person
Dr askari
Street address
sfahan University of Medical Sciences, School Nutrition, Research Center on Food Security
City
isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Food Security Research Center
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
food security research center
Full name of responsible person
mahdi foroughi
Position
msc student
Other areas of specialty/work
Street address
isfahan university medical science, school of nutrition
City
isfahan
Postal code
8174673461
Phone
+98 31 1523 6352
Fax
Email
MFOROGHI38@YAHOO.COMASKARI@MUI.AC.IR
Web page address
NUTR.MUI.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
isfahan university medical science, school of nutrition
Full name of responsible person
gholamreza askari
Position
assitance professor
Other areas of specialty/work
Street address
isfahan university medical science, school of nutrition
City
isfahan
Postal code
8174673461
Phone
+98 31 1792 2658
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
isfahan university medical science
Full name of responsible person
mahdi foroughi
Position
msc nutrition
Other areas of specialty/work
Street address
isfahan university medical science
City
isfahan
Postal code
8174673461
Phone
+98 31 1523 6352
Fax
Email
mforoghi38@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)