The Effect of Vitamin D Supplementation in Type 2 Diabetes (VD2000)
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|ClinicalTrials.gov Identifier: NCT01854463|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : May 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|DIABETES MELLITUS||Drug: Vitamin D3 Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||February 2013|
Experimental: Vitamin D3
25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks
Drug: Vitamin D3
2000IU per day
Other Name: dicamax d
Placebo Comparator: placebo
administered elemental calcium 200mg daily for 24 weeks
elemental calcium 200mg per day per 24 weeks
Other Name: calcium
- glycemic control [ Time Frame: 0, 12week, and 24week ]Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c
- arterial stiffenss [ Time Frame: at 0 and 24-week ]central blood pressure brachial-ankle pulse wave velocity aortic augmentation index
- non-alcoholic fatty liver diseases and bone turnover marker [ Time Frame: at 0 and 24- week ]precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854463
|Korea, Republic of|
|Chuncheon Sacred Heart Hospital|
|Chuncheon, Gangwon-do, Korea, Republic of, 200704|
|Principal Investigator:||OHKHYUN RYU, PROFESSOR||Hallym University Medical Center|