The Effect of Vitamin D Supplementation in Type 2 Diabetes

DIABETES MELLITUS Clinical Trial

— VD2000  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854463
• Other study ID #: CSHH2011-64
• Secondary ID: KDA2010
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2013
• Last updated: May 9, 2013
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: Chuncheon Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• DIABETES MELLITUS

Intervention

Drug:
• Vitamin D3
2000IU per day
• placebo
elemental calcium 200mg per day per 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Chuncheon Sacred Heart Hospital	Korean Diabetes Association

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	glycemic control	Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c	0, 12week, and 24week	Yes
Secondary	arterial stiffenss	central blood pressure brachial-ankle pulse wave velocity aortic augmentation index	at 0 and 24-week	Yes