The Effect of Vitamin D Supplementation in Type 2 Diabetes | NCT01854463

Studies
The Effect of Vitamin D Supplementation in Type 2 Diabetes

NCT01854463

Sponsor

Chuncheon Sacred Heart Hospital

Status

Completed

Last Update Posted

May 15, 2013Estimated

Enrollment

158Actual

Phase

Phase 4

Conditions

DIABETES MELLITUS

Interventions

Vitamin D3
placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KDA2010	Other Grant/Funding Number	Korean Diabetes Association year 2010 grant

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Apr 19, 2013

First Submission Date that Met QC Criteria

May 9, 2013

First Posted Date

May 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2013

Last Update Posted Date

May 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

OHKHYUN RYU, Assistant Professor, Chuncheon Sacred Heart HospitalPrincipal Investigator

Lead Sponsor

Chuncheon Sacred Heart HospitalOTHER

Collaborators

Name	Class
Korean Diabetes Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

158Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D3	Drug	2000IU per day	Vitamin D3	dicamax d

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glycemic control	Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c	0, 12week, and 24week

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
non-alcoholic fatty liver diseases and bone turnover marker	precontrast liver computed tomography AST, ALT calcium, PTH, bone specific alkaline phosphatase, serum CTX, calcium	at 0 and 24- week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
OHKHYUN RYU, PROFESSOR	Hallym University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chuncheon Sacred Heart Hospital		Chuncheon	Gangwon-do	200704	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23561637	Background	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.

ID	Term
D003920	Diabetes Mellitus
D005234	Fatty Liver

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D002762	Cholecalciferol
D002118	Calcium

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds