The Effect of Vitamin D Supplementation in Type 2 Diabetes

Phase 4

Completed

• Conditions: DIABETES MELLITUS
• Interventions: Drug: placebo; Drug: Vitamin D3

• Registration Number: NCT01854463
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2012-10
• Study Completion: 2013-02
• Study First Submitted: 2013-04-19
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-09
• Last Update Submitted: 2013-05-09
• Study First Posted: 2013-05-15
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	administered elemental calcium 200mg daily for 24 weeks
Vitamin D3	Vitamin D3	25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
glycemic control	0, 12week, and 24week	Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c

Secondary Outcome Measures

Name	Time	Method
arterial stiffenss	at 0 and 24-week	central blood pressure brachial-ankle pulse wave velocity aortic augmentation index

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of