The Effect of Vitamin D Supplementation in Type 2 Diabetes

NCT01854463 | Completed Phase 4 DMC

• 2 other identifiers: CSHH2011-64KDA2010
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

DIABETES MELLITUS

Keywords

DIABETES MELLITUS; VITAMIN D; ARTERIAL STIFFNESS; FATTY LIVER; BONE TURNOVER

Outcome Measures

Primary Outcomes (1)

• glycemic control

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

  0, 12week, and 24week

Secondary Outcomes (1)

• arterial stiffenss

  at 0 and 24-week

Other Outcomes (1)

• non-alcoholic fatty liver diseases and bone turnover marker

  at 0 and 24- week

Study Arms (2)

Vitamin D3

EXPERIMENTAL

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

Drug: Vitamin D3

placebo

PLACEBO COMPARATOR

administered elemental calcium 200mg daily for 24 weeks

Drug: placebo

Interventions

Vitamin D3 DRUG

2000IU per day

Also known as: dicamax d

Vitamin D3

placebo DRUG

elemental calcium 200mg per day per 24 weeks

Also known as: calcium

placebo

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• to 69 years
• \>=6.5% OR \<8.0% OF HbA1c

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Korean Diabetes Association: collaborator

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 200704, South Korea

Location

Related Publications (1)

• 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.

  PMID: 23561637 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Fatty Liver

Interventions

Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• OHKHYUN RYU, PROFESSOR

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 15, 2013
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

KR (1)