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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

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : February 2013


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 Name: dicamax d

Placebo Comparator: placebo
administered elemental calcium 200mg daily for 24 weeks
Drug: placebo
elemental calcium 200mg per day per 24 weeks
Other Name: calcium




Primary Outcome Measures :
  1. glycemic control [ Time Frame: 0, 12week, and 24week ]
    Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c


Secondary Outcome Measures :
  1. arterial stiffenss [ Time Frame: at 0 and 24-week ]
    central blood pressure brachial-ankle pulse wave velocity aortic augmentation index


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854463


Locations
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Korea, Republic of
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, Korea, Republic of, 200704
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Korean Diabetes Association
Investigators
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Principal Investigator: OHKHYUN RYU, PROFESSOR Hallym University Medical Center

Publications:
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Responsible Party: OHKHYUN RYU, Assistant Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01854463    
Other Study ID Numbers: CSHH2011-64
KDA2010 ( Other Grant/Funding Number: Korean Diabetes Association year 2010 grant )
First Posted: May 15, 2013    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Keywords provided by OHKHYUN RYU, Chuncheon Sacred Heart Hospital:
DIABETES MELLITUS
VITAMIN D
ARTERIAL STIFFNESS
FATTY LIVER
BONE TURNOVER
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Ergocalciferols
Calcium, Dietary
Cholecalciferol
Vitamins
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents