The Effect of Vitamin D Supplementation in Type 2 Diabetes

NCT ID: NCT01854463

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-02-28

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.

Conditions

DIABETES MELLITUS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vitamin D3

25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

2000IU per day

placebo

administered elemental calcium 200mg daily for 24 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

elemental calcium 200mg per day per 24 weeks

Interventions

Vitamin D3

2000IU per day

Intervention Type: DRUG

placebo

elemental calcium 200mg per day per 24 weeks

Intervention Type: DRUG

Other Intervention Names

dicamax d; calcium

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Diabetes Association

OTHER

Sponsor Role: collaborator

Chuncheon Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

OHKHYUN RYU

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

OHKHYUN RYU, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 23561637 (View on PubMed)

Other Identifiers

KDA2010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CSHH2011-64

Identifier Type: -

Identifier Source: org_study_id