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Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

Primary Purpose

Coronary Artery Disease, Postprandial Hyperglycemia, Vitamin D Deficiency

Status
Terminated
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
vitamin D
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring endothelial function, insulin sensitivity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 40-75
  • Postchallenge hyperglycemia (2h-whole blood glucose value in oral glucose tolerance test above 119 mg/dl, normal fasting glucose)
  • Angiographically verified coronary artery disease (>50% stenosis)
  • Serum 25-OH- vitamin D < 20 ng/ml in winter/spring/autumn and <25 ng/ml during june-september
  • Stable antihypertensive therapy in the last 3 month

Exclusion Criteria:

  • Acute coronary syndrome or cerebrovascular event within the previous 1 month
  • BMI > 40 kg/m²
  • Serum creatinine >2.5 times the upper limit of normal
  • GOT or GPT > 3 times the upper limit of normal
  • Heart failure > NYHA class II
  • Uncontrolled hypertension (>160/100 mmHg)
  • New onset of statins, ACE-inhibitors or ARBs within the previous 4 weeks
  • History of urolithiasis
  • Hypercalcaemia
  • Major psychiatric disorders
  • Ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamterene and aliskiren.
  • Treatment with antipsychotic drugs
  • Regular significant antioxidants, vitamins or protein supplementation
  • Immunosuppressive therapy
  • Glucocorticoid therapy
  • Ongoing chemotherapy
  • Pregnancy
  • Any other disease with an estimated life expectancy below 1 year.

Sites / Locations

  • Dept. of Internal Medicine, Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin D (Oleovit®)

Placebo

Arm Description

vitamin D drops

placebo drops

Outcomes

Primary Outcome Measures

endothelial dysfunction
Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)

Secondary Outcome Measures

insulin resistance and beta-cell function
Changes in indices for insulin resistance and beta-cell function

Full Information

First Posted
August 16, 2010
Last Updated
April 16, 2015
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01183442
Brief Title
Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia
Official Title
Effects of Vitamin D Supplementation in Coronary Artery Disease Patients With Postchallenge Hyperglycemia and Vitamin D Deficiency on Endothelial Function and Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
unable to recruit
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main aim of the investigation is to clarify, whether vitamin D supplementation in coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell function.
Detailed Description
An improvement of endothelial dysfunction as a cardiovascular surrogate parameter could be translated in a reduced risk for future cardiovascular events, which is of major interest, since patients with postchallenge hyperglycemia face a significantly higher cardiovascular risk than patients with normal glucose tolerance. Furthermore an improvement in insulin sensitivity and/or beta-cell function would identify vitamin D as an important strategy for the prevention of type 2 diabetes. In consideration of the rapidly increasing prevalence of diabetes and the failure of current prevention strategies this could be an important, safe and cheap way to support ongoing lifestyle modifying programs. Our study of course investigates surrogate cardiovascular and insulin sensitivity parameters. Assuming a beneficial effect of vitamin D in our study, this concept would have to be proven in further large outcome as well as diabetes prevention trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Postprandial Hyperglycemia, Vitamin D Deficiency
Keywords
endothelial function, insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D (Oleovit®)
Arm Type
Active Comparator
Arm Description
vitamin D drops
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo drops
Intervention Type
Drug
Intervention Name(s)
vitamin D
Other Intervention Name(s)
vitamin d (Oleovit®)
Intervention Description
orally administered 2800 IU of vitamin D or placebo daily
Primary Outcome Measure Information:
Title
endothelial dysfunction
Description
Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
insulin resistance and beta-cell function
Description
Changes in indices for insulin resistance and beta-cell function
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40-75 Postchallenge hyperglycemia (2h-whole blood glucose value in oral glucose tolerance test above 119 mg/dl, normal fasting glucose) Angiographically verified coronary artery disease (>50% stenosis) Serum 25-OH- vitamin D < 20 ng/ml in winter/spring/autumn and <25 ng/ml during june-september Stable antihypertensive therapy in the last 3 month Exclusion Criteria: Acute coronary syndrome or cerebrovascular event within the previous 1 month BMI > 40 kg/m² Serum creatinine >2.5 times the upper limit of normal GOT or GPT > 3 times the upper limit of normal Heart failure > NYHA class II Uncontrolled hypertension (>160/100 mmHg) New onset of statins, ACE-inhibitors or ARBs within the previous 4 weeks History of urolithiasis Hypercalcaemia Major psychiatric disorders Ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamterene and aliskiren. Treatment with antipsychotic drugs Regular significant antioxidants, vitamins or protein supplementation Immunosuppressive therapy Glucocorticoid therapy Ongoing chemotherapy Pregnancy Any other disease with an estimated life expectancy below 1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R. Pieber, MD
Organizational Affiliation
Medical University of Graz, Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Internal Medicine, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

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Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

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