Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200704, South Korea
NCT Number: NCT01854463
In many observational studies, vitamin D deficiency is related to glucose intolerance and diabetes. But there little randomized, controlled interventional studies that evaluate the effect of vitamin D in type 2 diabetes.
Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2 diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and bone turnover markers.
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Notify Me30 year–69 year
All sexes
Interventional
Phase 4
Chuncheon, Gangwon-do, 200704, South Korea
After informed consent, investigators randomized 180 type 2 diabetes into interventiona group (25-hydroxy vitamin d 2000 IU+ elemental calcium 200mg per day) or placebo group (elemental calcium 200mg per day). The participants should control diabetes by oral medications or lifestyle intervention at the intervention period. Investigators exclude the participants who took vitamin D or calcium or anti-osteoporotic drugs. Investigators also exclude renal insufficiency (Cr>1.5 in men or Cr>1.4 in women) or heavy alcoholics.
Investigators followed the participants for 24 weeks. After randomization, investigators checked HbA1c,glucose, calcium, 25-hydroxyvitamin d, AST, ALT,Creatinine, Parathyroid hormone, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, and aortic augmentation index, and precontrast liver computed tomography. Also investigators checked body weight, height, and peripheral blood pressure.
At 12 weeks, investigators checked HbA1c, 25-hydroxy vitamin D, AST, ALT, calcium, and creatinine.
At the end of the study(at 24 weeks), investigators checked HbA1c, glucose, AST, ALT, Creatinine, calcium, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, aortic augmentation index, and precontrast liver computed tomography.
After the study completed, investiators compared the data of interventional groups and placebo groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2000IU per day
Other names: dicamax d
elemental calcium 200mg per day per 24 weeks
Other names: calcium
Time frame: 0, 12week, and 24week
Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c
Time frame: at 0 and 24-week
central blood pressure brachial-ankle pulse wave velocity aortic augmentation index
Time frame: at 0 and 24- week
precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium
Chuncheon Sacred Heart Hospital
Other
The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes
Acronym: VD2000
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