Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia

NCT01183442 | Terminated Phase 3

• 1 other identifier: ENM-DA012
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Postprandial Hyperglycemia; Vitamin D Deficiency

Keywords

endothelial function; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• endothelial dysfunction

  Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)

  1 year

Secondary Outcomes (1)

• insulin resistance and beta-cell function

  1 year

Study Arms (2)

vitamin D (Oleovit®)

ACTIVE COMPARATOR

vitamin D drops

Drug: vitamin D

Placebo

PLACEBO COMPARATOR

placebo drops

Drug: vitamin D

Interventions

vitamin D DRUG

orally administered 2800 IU of vitamin D or placebo daily

Also known as: vitamin d (Oleovit®)

Placebo; vitamin D (Oleovit®)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Dept. of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hyperglycemia; Vitamin D Deficiency; Insulin Resistance

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Thomas R. Pieber, MD

  Medical University of Graz, Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

AU (1)