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

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ClinicalTrials.gov Identifier: NCT01854463
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
Korean Diabetes Association
Information provided by (Responsible Party):
OHKHYUN RYU, Chuncheon Sacred Heart Hospital

Tracking Information
First Submitted Date  ICMJE April 19, 2013
First Posted Date  ICMJE May 15, 2013
Last Update Posted Date May 15, 2013
Study Start Date  ICMJE December 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
glycemic control [ Time Frame: 0, 12week, and 24week ]
Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
arterial stiffenss [ Time Frame: at 0 and 24-week ]
central blood pressure brachial-ankle pulse wave velocity aortic augmentation index
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2013)
non-alcoholic fatty liver diseases and bone turnover marker [ Time Frame: at 0 and 24- week ]
precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Vitamin D Supplementation in Type 2 Diabetes
Official Title  ICMJE The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE DIABETES MELLITUS
Intervention  ICMJE
  • Drug: Vitamin D3
    2000IU per day
    Other Name: dicamax d
  • Drug: placebo
    elemental calcium 200mg per day per 24 weeks
    Other Name: calcium
Study Arms  ICMJE
  • Experimental: Vitamin D3
    25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks
    Intervention: Drug: Vitamin D3
  • Placebo Comparator: placebo
    administered elemental calcium 200mg daily for 24 weeks
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2013)
158
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01854463
Other Study ID Numbers  ICMJE CSHH2011-64
KDA2010 ( Other Grant/Funding Number: Korean Diabetes Association year 2010 grant )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OHKHYUN RYU, Chuncheon Sacred Heart Hospital
Study Sponsor  ICMJE Chuncheon Sacred Heart Hospital
Collaborators  ICMJE Korean Diabetes Association
Investigators  ICMJE
Principal Investigator: OHKHYUN RYU, PROFESSOR Hallym University Medical Center
PRS Account Chuncheon Sacred Heart Hospital
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP