The Effect of Vitamin D Supplementation in Type 2 Diabetes (VD2000)

Chuncheon Sacred Heart Hospital

Status and phase: Completed; Phase 4

Conditions: DIABETES MELLITUS

Treatments: Drug: Vitamin D3; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01854463

CSHH2011-64

KDA2010 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 158 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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158 participants in 2 patient groups, including a placebo group

Vitamin D3

Experimental group

Description:

25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks

Treatment:

Drug: Vitamin D3

placebo

Placebo Comparator group

Description:

administered elemental calcium 200mg daily for 24 weeks

Treatment:

Drug: placebo