Status:
TERMINATED
Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia
Lead Sponsor:
Medical University of Graz
Conditions:
Coronary Artery Disease
Postprandial Hyperglycemia
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
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 endoth...
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01183442
Start Date
June 1 2010
End Date
November 1 2012
Last Update
April 17 2015
Active Locations (1)
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1
Dept. of Internal Medicine, Medical University of Graz
Graz, Austria, 8036