Clinical trial NCT01854463: The Effect of Vitamin D Supplementation in Type 2 Diabetes
Official title: The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: DIABETES MELLITUS
Keywords: DIABETES MELLITUS
VITAMIN D
ARTERIAL STIFFNESS
FATTY LIVER
BONE TURNOVER
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Korean Diabetes Association
First posted: 2013-05-15
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: glycemic control
timeFrame: 0, 12week, and 24week
Secondary outcomes:
measure: arterial stiffenss
timeFrame: at 0 and 24-week
Other outcomes:
measure: non-alcoholic fatty liver diseases and bone turnover marker
timeFrame: at 0 and 24- week
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
affiliation: Hallym University Medical Center
name: OHKHYUN RYU, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.