Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01183442
• Other study ID #: ENM-DA012
• Status: Terminated
• Phase: Phase 3
• First received: August 16, 2010
• Last updated: April 16, 2015
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hyperglycemia
• Myocardial Ischemia
• Postprandial Hyperglycemia
• Vitamin D Deficiency

Intervention

Drug:
• vitamin D
orally administered 2800 IU of vitamin D or placebo daily

Locations

Country	Name	City	State
Austria	Dept. of Internal Medicine, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endothelial dysfunction	Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)	1 year	No
Secondary	insulin resistance and beta-cell function	Changes in indices for insulin resistance and beta-cell function	1 year	No