VD2000: The Effect of Vitamin D Supplementation in Type 2 Diabetes

Sponsor

Chuncheon Sacred Heart Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01854463

Collaborator

Korean Diabetes Association (Other)

158

Enrollment

Location

Arms

14.1

Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 :

Dec 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D3 25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks	Drug: Vitamin D3 2000IU per day Other Names: dicamax d
Placebo Comparator: placebo administered elemental calcium 200mg daily for 24 weeks	Drug: placebo elemental calcium 200mg per day per 24 weeks Other Names: calcium

Arm

Intervention/Treatment

Experimental: Vitamin D3

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

Drug: Vitamin D3

2000IU per day

Other Names:

dicamax d

Placebo Comparator: placebo

administered elemental calcium 200mg daily for 24 weeks

Drug: placebo

elemental calcium 200mg per day per 24 weeks

Other Names:

calcium

Outcome Measures

Primary Outcome Measures

glycemic control [0, 12week, and 24week]
Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c

Secondary Outcome Measures

arterial stiffenss [at 0 and 24-week]
central blood pressure brachial-ankle pulse wave velocity aortic augmentation index

Other Outcome Measures

non-alcoholic fatty liver diseases and bone turnover marker [at 0 and 24- week]
precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 69 Years

Sexes Eligible for Study:

All

Accepts 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