A Phase 4 interventional study of Vitamin D3 and placebo in DIABETES MELLITUS, sponsored by Chuncheon Sacred Heart Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2013-05-15.
Sponsored by Chuncheon Sacred Heart Hospital · Phase 4, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 158 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Chuncheon Sacred Heart Hospital is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks
Drug: Vitamin D3
administered elemental calcium 200mg daily for 24 weeks
Drug: placebo
2000IU per day
Also known as: dicamax d
elemental calcium 200mg per day per 24 weeks
Also known as: calcium
glycemic control
Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c
Time frame: 0, 12week, and 24week
arterial stiffenss
central blood pressure brachial-ankle pulse wave velocity aortic augmentation index
Time frame: at 0 and 24-week
non-alcoholic fatty liver diseases and bone turnover marker
precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium
Time frame: at 0 and 24- week
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Chuncheon Sacred Heart Hospital