Effects of vitamin D supplementation in coronary artery disease patients with postchallenge hyperglycemia and vitamin D deficiency on endothelial function and insulin sensivitivity

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015776-95-AT

Enrollment

Unknown

Registered

2010-03-01

Start date

2010-03-24

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subjects with coronary artery disease, postchallenge hyperglycemia and low levels of 24-OH-vitamin D

Interventions

Trade Name: Oleovit D3 Product Name: Oleovit D3 Product Code: 10.989 Pharmaceutical Form: Oral drops* INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Current Sponsor code: 10.989 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 40-75 - Postchallenge hyperglycemia (2h value in oral glucose tolerance test above 139mg/dl, normal fasting glucose) - Angiographically verified coronary artery disease (>50% stenosis) - Serum 25-OH- vitamin D =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 • Hypercalaemia • Major psychiatric disorders • Ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamteren and aliskiren. • immunosuppressive therapy • glucocorticoid therapy • ongoing chemotherapy • pregnancy • any other disease with an estimated life expectancy below 1 year.

Design outcomes

Primary

Measure	Time frame
Main Objective: Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) by vitamin D supplementation.;Primary end point(s): Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) ;Secondary Objective: Changes in indices for insulin resistance and beta-cell function. Changes in blood pressure. Changes in markers of chronic inflammation Changes in levels of renin and aldosterone Changes in levels of NT-proBNP	—

Measure

Time frame

Main Objective: Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) by vitamin D supplementation.;Primary end point(s): Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) ;Secondary Objective: Changes in indices for insulin resistance and beta-cell function. Changes in blood pressure. Changes in markers of chronic inflammation Changes in levels of renin and aldosterone Changes in levels of NT-proBNP

—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026