The Effect of Vitamin D Supplementation in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes

Conditions
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DIABETES MELLITUS

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TYPE 2 DIABETES MELLITUS PATIENTS WHO CONTROL GLUCOSE BY ORAL ANTIBIABETIC DRUGS OR LIFESTYLE ONLY DID NOT CHANGE ANTIDIABETIC DRUG BEFORE THE STUDY FOR 2 MONTHS normal physical activity 30 to 69 years >=6.5% OR <8.0% OF HbA1c Exclusion Criteria: Creatinine>1.5 in men, >1.4 in women heavy alcoholics who took calcium or vitamin d or anti-osteoporosis drug within 3 months before the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3<br>25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks | Drug: Vitamin D3<br>* 2000IU per day<br>* Other names: dicamax d;|
| Placebo Comparator: placebo<br>administered elemental calcium 200mg daily for 24 weeks | Drug: placebo<br>* elemental calcium 200mg per day per 24 weeks<br>* Other names: calcium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control | Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c | 0, 12week, and 24week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial stiffenss | central blood pressure brachial-ankle pulse wave velocity aortic augmentation index | at 0 and 24-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIABETES MELLITUS, VITAMIN D, ARTERIAL STIFFNESS, FATTY LIVER, BONE TURNOVER