Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

This study has suspended participant recruitment.
(unable to recruit)
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01183442
First received: August 16, 2010
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Postprandial Hyperglycemia
Vitamin D Deficiency
Drug: vitamin D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • endothelial dysfunction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)


Secondary Outcome Measures:
  • insulin resistance and beta-cell function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Changes in indices for insulin resistance and beta-cell function


Estimated Enrollment: 140
Study Start Date: June 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin D (Oleovit®) Drug: vitamin D
orally administered 2800 IU of vitamin D or placebo daily
Other Name: vitamin d (Oleovit®)
Placebo Comparator: Placebo Drug: vitamin D
orally administered 2800 IU of vitamin D or placebo daily
Other Name: vitamin d (Oleovit®)

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183442

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

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01183442     History of Changes
Other Study ID Numbers: ENM-DA012
Study First Received: August 16, 2010
Last Updated: October 31, 2012
Health Authority: Austria: Agency for Health and Food Safety

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hyperglycemia
Vitamin D Deficiency
Insulin Resistance
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperinsulinism
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 23, 2014