Coronary Artery DiseasePhase 3VINCA-CKDNCT01012414
Effect of Vitamin D Supplement on Inflammation Markers in High-Risk Cardiovascular Patients With Chronic Kidney Disease
A Phase 3 study testing paricalcitol in people with Coronary Artery Disease and Chronic Kidney Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Chronic Kidney Disease, Hypovitaminosis D
- What is being tested?
- paricalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and non-pregnant, non-lactating women greater than 18 years of age
- Able to given informed consent and complete scheduled visits
- History of established coronary artery disease (CAD)as defined by coronary stenosis in one or more vessels greater than or equal to 70% by coronary angiography or CT angiogram OR abnormal stress test (at least medium-sized, moderate reversible defect) OR a presence of a CAD risk equivalent as defined by the National Cholesterol Education Panel (NCEP)III as: Framingham risk score ≥ 20%, diabetes, or peripheral arterial disease(4)
- High Sensitivity C-reactive Protein (hs-CRP) ≥ 2.0 mg/L
- History of stage 3 or 4 chronic Kidney disease (CKD) defined as an glomerular filtration rate (eGRF) by the Modification of Diet in Renal Disease (MDRD) formula of 15-60 mL/min/1.73 m2
- Low level of serum 25-hydroxyvitamin D (<30ng/mL)
- Evidence of secondary hyperparathyroidism defined as intact parathyroid hormone (iPTH) level > 70 pg/mL
- Stable dose of statin and/or other lipid lowering therapy (ie: ezetimibe, fibrates, bile acid sequestrants nicotinic acid, fish oil) for 12 weeks prior to enrollment without known plans for change to current therapy during the study period
Who cannot join
- History of myocardial infarction, stroke, or cardiac surgery within 6 months of enrollment
- History of carotid artery surgery
- Planned cardiovascular surgery or procedure, with the exception of permanent pacemaker placement, in the next 18 months.
- Use of vitamin D or calcium supplementation within the past 12 weeks with the exception of calcium containing phosphate binders and a daily multivitamin containing ≤ 400 IU of vitamin D
- Hypercalcemia (as defined by the laboratory upper limit of normal ) or hyperphosphatemia (≥ 5.5 mg/dL)
- Plan to initiate renal replacement therapy (dialysis) during the study
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- History of left ventricular systolic dysfunction with an ejection fraction <50% or history of New York Heart Association (NYHA)functional Class II-IV congestive heart failure
- Uncontrolled blood pressure, defined as systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 100 mm Hg at the screening visit
- Uncontrolled diabetes, defined as hemoglobin A1C ≥ 10.0
- History of any surgery within the past 3 months or known to be planned during the study period
- History of malignancy within the past 5 years with the exception of non-melanoma (ie: squamous cell or basal cell) skin cancer
- History of a known systemic or pulmonary inflammatory condition (including rheumatoid arthritis, systemic lupus erythematosus, chronic obstructive pulmonary disease, pulmonary fibrosis, sarcoidosis, Wegener's granulomatosis, Goodpasture's disease)
- History of renal or other organ transplant and/or immunosuppressed state (ie immunosuppressive therapy or condition such as HIV)
- History of any other condition, that in the opinion of the investigators renders it unsafe for the subject to be enrolled
- For woman able to become pregnant, unwillingness to use birth control
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effect of Vitamin D Supplementation on Markers of Inflammation in High-Risk Cardiovascular Patients With Low Levels of Serum 25-Hydroxyvitamin D
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.
Read the detailed description
Vitamin D deficiency is common and has been associated with an increased risk of heart disease. In patients with the combination of kidney disease and heart disease, inflammation is thought to contribute to a high rate of cardiac events. Less is known about the effects of vitamin D supplementation on certain tests associated with inflammation in the body.
- Conditions
- Coronary Artery Disease, Chronic Kidney Disease, Hypovitaminosis D, Secondary Hyperparathyroidism
- Being tested
- paricalcitol, placebo
- Keywords
- Vitamin D, Coronary Artery Disease (CAD), Chronic Kidney Disease (CKD)
- Medical subject headings
- Coronary Artery Disease, Renal Insufficiency, Chronic, Vitamin D Deficiency, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
Also called Zemplar
2 mcg oral paricalcitol daily
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| oral paricalcitol 2 mcg daily | Experimental | oral paricalcitol 2 mcg daily Receives: Drug: paricalcitol |
| Placebo | Placebo comparator | one oral placebo drug daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in High Sensitivity-C Reactive Protein (Serum)
Measured: 1 year
Secondary outcomes (3)
Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A
Measured: 1 year
Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.
Measured: 1 year
Effect on Carotid Intima-media Thickening (CIMT)
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 posted13 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Futility in enrollment as of May 31, 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- David J Whellan, MD MHS, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012414
- Sponsor's protocol ID
- 09C.110
- Acronym
- VINCA-CKD
- Status last verified
- May 2014
- First submitted
- 11 Nov 2009
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Markers of Inflammation in High-Risk Cardiovascular Patients With Low Levels of Serum 25-Hydroxyvitamin D
- ClinicalTrials.gov ID
- NCT01012414
- Acronym / sponsor ID
- VINCA-CKD / 09C.110
- Conditions
- Coronary Artery Disease, Chronic Kidney Disease, Hypovitaminosis D, Secondary Hyperparathyroidism
- Keywords
- Vitamin D, Coronary Artery Disease (CAD), Chronic Kidney Disease (CKD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility in enrollment as of May 31, 2011
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 11 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.
Detailed description
Vitamin D deficiency is common and has been associated with an increased risk of heart disease. In patients with the combination of kidney disease and heart disease, inflammation is thought to contribute to a high rate of cardiac events. Less is known about the effects of vitamin D supplementation on certain tests associated with inflammation in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral paricalcitol 2 mcg daily | Experimental | Drug: paricalcitoloral paricalcitol 2 mcg daily |
| Placebo | Placebo comparator | Drug: placeboone oral placebo drug daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and non-pregnant, non-lactating women greater than 18 years of age
- Able to given informed consent and complete scheduled visits
- History of established coronary artery disease (CAD)as defined by coronary stenosis in one or more vessels greater than or equal to 70% by coronary angiography or CT angiogram OR abnormal stress test (at least medium-sized, moderate reversible defect) OR a presence of a CAD risk equivalent as defined by the National Cholesterol Education Panel (NCEP)III as: Framingham risk score ≥ 20%, diabetes, or peripheral arterial disease(4)
- High Sensitivity C-reactive Protein (hs-CRP) ≥ 2.0 mg/L
- History of stage 3 or 4 chronic Kidney disease (CKD) defined as an glomerular filtration rate (eGRF) by the Modification of Diet in Renal Disease (MDRD) formula of 15-60 mL/min/1.73 m2
Key exclusion criteria (16 listed)
- History of myocardial infarction, stroke, or cardiac surgery within 6 months of enrollment
- History of carotid artery surgery
- Planned cardiovascular surgery or procedure, with the exception of permanent pacemaker placement, in the next 18 months.
- Use of vitamin D or calcium supplementation within the past 12 weeks with the exception of calcium containing phosphate binders and a daily multivitamin containing ≤ 400 IU of vitamin D
- Hypercalcemia (as defined by the laboratory upper limit of normal ) or hyperphosphatemia (≥ 5.5 mg/dL)
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 |
|---|---|---|
| paricalcitolAlso: Zemplar2 mcg oral paricalcitol daily | Drug | oral paricalcitol 2 mcg daily |
| placeboplacebo | Drug | Placebo |
Primary outcome
Change in High Sensitivity-C Reactive Protein (Serum)
Time frame: 1 year
3 secondary outcomes
Change in Markers of Inflammation Including Interleukin (IL)-1, IL-6, Tumor Necrosis Factor Alpha, Matrix Metalloproteinase (MMP) -9 and Serum Amyloid A
Time frame: 1 year
Effect on Known Coronary Artery Disease Risk Factors Including Lipids and Blood Pressure.
Time frame: 1 year
Effect on Carotid Intima-media Thickening (CIMT)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David J Whellan, MD MHS principal investigator
Thomas Jefferson University
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 paricalcitol in people with Coronary Artery Disease and Chronic Kidney Disease, run by Thomas Jefferson University at 1 site in United States.
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 8 inclusion and 16 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 20 May 2014. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in High Sensitivity-C Reactive Protein (Serum) (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 20 May 2014.