Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

Phase 3

Terminated

• Conditions: Coronary Artery Disease; Postprandial Hyperglycemia; Vitamin D Deficiency
• Interventions: Drug: vitamin D

• Registration Number: NCT01183442
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D (Oleovit®)	vitamin D	vitamin D drops
Placebo	vitamin D	placebo drops

Primary Outcome Measures

Name	Time	Method
endothelial dysfunction	1 year	Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)

Secondary Outcome Measures

Name	Time	Method
insulin resistance and beta-cell function	1 year	Changes in indices for insulin resistance and beta-cell function

Trial Locations

Locations (1)

Dept. of Internal Medicine, Medical University of Graz; 🇦🇹 Graz, Austria