|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
KCT |
|
Last refreshed on:
|
27 April 2013 |
|
Main ID: |
KCT0000406 |
|
Date of registration:
|
17/04/2012 |
|
Primary sponsor: |
|
|
Public title:
|
The effect of vitamin D on the glycemic control and non-alcoholic fatty liver disease
|
|
Scientific title:
|
The effect of vitamin D on the glycemic control and non-alcoholic fatty liver disease |
|
Date of first enrolment:
|
2011-12-16 |
|
Target sample size:
|
180 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=1723 |
|
Study type:
|
Interventional Study |
|
Study design:
|
Primary Purpose : Treatment, Intervention Model : Parallel, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Allocation : RCT
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Ohk Hyun
Ryu |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hallym University College of Medicine, Chuncheon Sacred Heart Hospital |
|
|
Name:
|
Ohk Hyun
Ryu |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hallym University College of Medicine, Chuncheon Sacred Heart Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Type 2 diabetic patients whose A1C between 6.5% and 8.4%
or non-alcoholic fatty liver disease patients whose body mass index >23kg/m2
Exclusion criteria: diabetic medication changed within 2 months
vitamin D or Osteoporosis treatment
Alcoholics
Renal insufficiency (Male Cr>1.5, Female Cr>1.4)
Viral hepatitis or Liver cirrhosis
Age minimum:
30(Year)
Age maximum:
69(Year)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
|
|
Endocrine, nutritional and metabolic disease
|
|
Intervention(s)
|
Drug : Partipants will be randomized into two groups (intervention vs placebo) The number of participants will be 180. Participants will take Vitamin D 2000 IU or placebo for 24 weeks.
|
|
Secondary Outcome(s)
|
|
Fatty liver by abdominal computed tomography
|
|
Source(s) of Monetary Support
|
|