Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

Medical University of Graz

Status and phase: Terminated; Phase 3

Conditions: Coronary Artery Disease; Postprandial Hyperglycemia; Vitamin D Deficiency

Treatments: Drug: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01183442

ENM-DA012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

vitamin D (Oleovit®)

Active Comparator group

Description:

vitamin D drops

Treatment:

Drug: vitamin D

Placebo

Placebo Comparator group

Description:

placebo drops

Treatment:

Drug: vitamin D