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Completed

NCT Number: NCT01854463

The Effect of Vitamin D Supplementation 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.

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Key information

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 200704, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

2000IU per day

Other names: dicamax d

Placebo

Drug

elemental calcium 200mg per day per 24 weeks

Other names: calcium

Primary outcomes

  1. glycemic control

    Time frame: 0, 12week, and 24week

    Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c

Secondary outcomes

  1. arterial stiffenss

    Time frame: at 0 and 24-week

    central blood pressure brachial-ankle pulse wave velocity aortic augmentation index

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Collaborators

  • Korean Diabetes Association

Registry information

Official study title

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

Acronym: VD2000

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 15, 2013
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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