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Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

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ClinicalTrials.gov Identifier: NCT01183442
Recruitment Status : Terminated (unable to recruit)
First Posted : August 17, 2010
Last Update Posted : April 17, 2015
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Postprandial Hyperglycemia Vitamin D Deficiency Drug: vitamin D Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2010
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: vitamin D (Oleovit®)
vitamin D drops
Drug: vitamin D
orally administered 2800 IU of vitamin D or placebo daily
Other Name: vitamin d (Oleovit®)
Placebo Comparator: Placebo
placebo drops
Drug: vitamin D
orally administered 2800 IU of vitamin D or placebo daily
Other Name: vitamin d (Oleovit®)

Primary Outcome Measures :
  1. endothelial dysfunction [ Time Frame: 1 year ]
    Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)

Secondary Outcome Measures :
  1. insulin resistance and beta-cell function [ Time Frame: 1 year ]
    Changes in indices for insulin resistance and beta-cell function

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183442

Dept. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Thomas R. Pieber, MD Medical University of Graz, Graz, Austria

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01183442     History of Changes
Other Study ID Numbers: ENM-DA012
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Medical University of Graz:
endothelial function
insulin sensitivity

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Insulin Resistance
Vitamin D Deficiency
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hypoglycemic Agents