Investigation of the effect of vitamin D supplementation on improvement of liver function test in type 2 diabetic patients who have both vitamin D deficiency and nonalcoholic fatty liver disease
This clinical trial study is designed to verify the hypothesis that providing vitamin D supplement to type 2 diabetic patients with nonalcoholic fatty liver disease and vitamin D deficiency might improve liver function test. 115 diabetic patients will be evaluated for fatty liver change (by ultrasound) and serum biochemical markers (liver function test (LFT), fasting blood sugar , HbA1c, lipid profile, and vitamin D level). patients who are consuming drugs that have the potential to cause fatty liver will be excluded. Those patients who have both nonalcoholic fatty liver disease and vitamin D deficiency will be provided with 50000 IU vitamin D/week orally for 12 weeks. One week after the last does the same biochemical markers will be evaluated and compared with those before treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020816528N1
Registration date:2014-05-03, 1393/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Alireza Alireza
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1624 7819
Email address
dabbaghmanesh@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-04-29, 1393/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of vitamin D supplementation on improvement of liver function test in type 2 diabetic patients who have both vitamin D deficiency and nonalcoholic fatty liver disease
Public title
Effect of vitamin D supplementation on nonalcoholic fatty liver disease in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
known case of type II diabetes who have been treated for at least 6 months
exclusion criteria:
positive history of alcohol use; positive history of hepatitis B or C; chronic liver or renal disease; consumption of drugs known to cause fatty liver change (such as estrogen, metotrexate, Tamoxifen, Tetracyclin, Oral contraceptive pills, sodium valporate); pregnancy or lactation; positive history of thyroid disease
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
115
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord university of medical sciences
Street address
Shahrekord university of medical sciences, Shahrekord, Iran
City
Sharekord
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1071
Health conditions studied
1
Description of health condition studied
nonalcoholic fatty liver
ICD-10 code
k76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
liver enzymes(AST, ALT, GGT)
Timepoint
at the begining of the study and 1 week after the last dose of vitamin D supplement
Method of measurement
ELISA
Secondary outcomes
1
Description
Lipid profile ( cholesterol, HDL, LDL, TG)
Timepoint
at the begining of the study and 1 week after the last dose of vitamin D supplement
Method of measurement
spectrophotometry
2
Description
HbA1C
Timepoint
at the begining of the study and 1 week after the last dose of vitamin D supplement
Method of measurement
HPLC
3
Description
(fasting blood sugar) FBS
Timepoint
at the begining of the study and 1 week after the last dose of vitamin D supplement
Method of measurement
spectrophotometry
Intervention groups
1
Description
In the intervention group vitamin D pearl (50000 IU) is administered orally one pearl per week for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mitra Saadat
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord university of medical sciences, Shahrekord, Iran