Coronary Artery DiseasePhase 3NCT01183442
Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia
A Phase 3 study testing vitamin D in people with Coronary Artery Disease and Postprandial Hyperglycemia, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Postprandial Hyperglycemia, Vitamin D Deficiency
- What is being tested?
- vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2010to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Internal Medicine, Medical University of Graz
Graz, 8036
About this study
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
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.
Read the 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.
- Being tested
- vitamin D
- Keywords
- endothelial function, insulin sensitivity
- Medical subject headings
- Coronary Artery Disease, Hyperglycemia, Vitamin D Deficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDrug
Also called vitamin d (Oleovit®)
orally administered 2800 IU of vitamin D or placebo daily
| Study group | Role | What they receive |
|---|---|---|
| vitamin D (Oleovit®) | Active comparator | vitamin D drops Receives: Drug: vitamin D |
| Placebo | Placebo comparator | placebo drops Receives: Drug: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial dysfunction
Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)
Measured: 1 year
Secondary outcomes (1)
insulin resistance and beta-cell function
Changes in indices for insulin resistance and beta-cell function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R. Pieber, MD, Principal investigator, Medical University of Graz, Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183442
- Sponsor's protocol ID
- ENM-DA012
- Status last verified
- Apr 2015
- First submitted
- 16 Aug 2010
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01183442
- Acronym / sponsor ID
- ENM-DA012
- Keywords
- endothelial function, insulin sensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D (Oleovit®) | Active comparator | Drug: vitamin Dvitamin D drops |
| Placebo | Placebo comparator | Drug: vitamin Dplacebo drops |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin DAlso: vitamin d (Oleovit®)orally administered 2800 IU of vitamin D or placebo daily | Drug | Placebo, vitamin D (Oleovit®) |
Primary outcome
endothelial dysfunction
Time frame: 1 year
Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical)
1 secondary outcome
insulin resistance and beta-cell function
Time frame: 1 year
Results and safety
The study was stopped early (reason given: unable to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R. Pieber, MD principal investigator
Medical University of Graz, Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vitamin D in people with Coronary Artery Disease and Postprandial Hyperglycemia, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: unable to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial dysfunction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.