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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: CHUNCHEON SACRED HEART HOSPITAL
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.
Primary Outcome(s)
HbA1C
Secondary Outcome(s)
Fatty liver by abdominal computed tomography
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
CHUNCHEON SACRED HEART HOSPITAL
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