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

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

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.

Study Overview

• Status: Completed
• Conditions: DIABETES MELLITUS
• Intervention / Treatment: Drug: Vitamin D3; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Chuncheon, Gangwon-do, Korea, Republic of, 200704
      • Chuncheon Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-alcoholic fatty liver diseases and bone turnover marker	precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium	at 0 and 24- week

Collaborators and Investigators

• Sponsor: Chuncheon Sacred Heart Hospital
• Collaborators: Korean Diabetes Association
• Investigators: Principal Investigator: OHKHYUN RYU, PROFESSOR, Hallym University Medical Center

Publications and helpful links

General Publications

• Breslavsky A, Frand J, Matas Z, Boaz M, Barnea Z, Shargorodsky M. Effect of high doses of vitamin D on arterial properties, adiponectin, leptin and glucose homeostasis in type 2 diabetic patients. Clin Nutr. 2013 Dec;32(6):970-5. doi: 10.1016/j.clnu.2013.01.020. Epub 2013 Feb 27.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 15, 2013

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 9, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: VITAMIN D; DIABETES MELLITUS; ARTERIAL STIFFNESS; FATTY LIVER; BONE TURNOVER
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: CSHH2011-64; KDA2010 (Other Grant/Funding Number: Korean Diabetes Association year 2010 grant)