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Vitamin D Supplementation on Cardiovascular Risk Factors

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Cholecalciferol, Vitamin D, Insulin resistance, Cardiovascular disease risk, Minorities

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • African American or Hispanic
  • able to ambulate on their own
  • aged between 30 - 70 years

Exclusion Criteria:

  • Taking Supplemental Vitamin D
  • Pregnant or Lactating women
  • Receiving insulin therapy
  • Not participating in other drug trials
  • HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders
  • Kidney failure or on dialysis

Sites / Locations

  • Human Nutrition Laboratory, Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

4000 IU group

6000 IU group

Arm Description

This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.

This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.

Outcomes

Primary Outcome Measures

Blood Lipid
Total cholesterol will be used as surrogate measures for cardiovascular disease risk.

Secondary Outcome Measures

Glycemic Control
hemoglobin A1C blood test

Full Information

First Posted
August 7, 2011
Last Updated
November 13, 2017
Sponsor
Florida International University
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1. Study Identification

Unique Protocol Identification Number
NCT01412710
Brief Title
Vitamin D Supplementation on Cardiovascular Risk Factors
Official Title
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida International University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.
Detailed Description
Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population. Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke. These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD. Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Cholecalciferol, Vitamin D, Insulin resistance, Cardiovascular disease risk, Minorities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4000 IU group
Arm Type
Experimental
Arm Description
This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.
Arm Title
6000 IU group
Arm Type
Experimental
Arm Description
This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
Primary Outcome Measure Information:
Title
Blood Lipid
Description
Total cholesterol will be used as surrogate measures for cardiovascular disease risk.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Glycemic Control
Description
hemoglobin A1C blood test
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes African American or Hispanic able to ambulate on their own aged between 30 - 70 years Exclusion Criteria: Taking Supplemental Vitamin D Pregnant or Lactating women Receiving insulin therapy Not participating in other drug trials HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders Kidney failure or on dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma G Huffman, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Laboratory, Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States

12. IPD Sharing Statement

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Vitamin D Supplementation on Cardiovascular Risk Factors

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