Cardiovascular DiseaseNCT01018849
Role of Vitamin D in Secondary Prevention of Cardiovascular Events
A study testing Cholecalciferol in people with Cardiovascular Disease, run by Creighton University at 2 sites in United States.
Trial summary
The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to May 2015
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of age > 19 years at the time informed consent is signed.
- Subject with a diagnosis of unstable angina (with Thrombolysis in Myocardial Infarction (TIMI) score of greater than or equal to 3) / NSTEMI or STEMI,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
- Subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.
Who cannot join
- Subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin D deficiency).
- Subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin D metabolism).
- Subject is on an investigational drug, which is a new drug class and not part of standard ACS protocol.
- Subject is taking supplements of vitamin D with doses >400 IU/day.
- Subject has hypersensitivity to vitamin D products.
- Subject has history of systemic lupus erythematosus (since vitamin D deficiency is common in this group27).
Show all 14Show fewer
- Subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin D28)
- Subject has history of renal stones.
- Subject has hypercalcemia, which is defined as serum calcium levels >10.6 mg/dl, at the time of screening.
- Subject has end stage renal disease, defined as either chronic kidney disease stage V or requiring dialysis (since these patients have altered vitamin D and calcium metabolism).
- Subject has systemic disease (including terminal cancer, cirrhosis, end stage COPD etc.,) with reduced (<12 months) life expectancy.
- Subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
- Subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
- Subject is pregnant.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Cardiac Center at Creighton University
Omaha, Nebraska, 68131
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.
Read the detailed description
The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.
- Conditions
- Cardiovascular Disease
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Vitamin D, Cardiac Catheterization, Cardiovascular event, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called Vitamin D3
cholecalciferol 150,000 IU by mouth every 2 months for 1 year
PlaceboDietary supplement
placebo by mouth every 2 months for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (cholecalciferol) | Active comparator | Subjects receive 150,000 IU of Vitamin D3 every 2 months Receives: Dietary Supplement: Cholecalciferol |
| Placebo | Placebo comparator | Subject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml.
Measured: 1 year
To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD).
Measured: 1 year
Secondary outcomes (4)
To see if higher serum 25(OH) D levels will help in better control of blood pressure.
Measured: 1 year
To perform proteomics analysis to: a) Extract total protein; b) Profile protein expression in 2-DE and /or 2-DLC and direct mass spectrometric analysis (dMS) on the serum of vitamin D supplemented and placebo subjects.
Measured: 1 year
To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects.
Measured: 1 year
To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease
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 posted25 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Armas, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018849
- Sponsor's protocol ID
- 08-15149
- Status last verified
- Jan 2016
- First submitted
- 20 Nov 2009
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D in Secondary Prevention of Cardiovascular Events
- ClinicalTrials.gov ID
- NCT01018849
- Acronym / sponsor ID
- 08-15149
- Conditions
- Cardiovascular Disease
- Keywords
- Vitamin D, Cardiac Catheterization, Cardiovascular event, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Nov 2009 (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 purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.
Detailed description
The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D (cholecalciferol) | Active comparator | Dietary Supplement: CholecalciferolSubjects receive 150,000 IU of Vitamin D3 every 2 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubject will receive a placebo - an exact replica of the Vitamin D3 capsule that does not contain the active ingredient, Vitamin D3 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female of age > 19 years at the time informed consent is signed.
- Subject with a diagnosis of unstable angina (with Thrombolysis in Myocardial Infarction (TIMI) score of greater than or equal to 3) / NSTEMI or STEMI,or documented coronary artery disease defined as at least one coronary artery with > 50% occlusion
- Subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.
Key exclusion criteria (14 listed)
- Subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin D deficiency).
- Subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin D metabolism).
- Subject is on an investigational drug, which is a new drug class and not part of standard ACS protocol.
- Subject is taking supplements of vitamin D with doses >400 IU/day.
- Subject has hypersensitivity to vitamin D products.
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D3cholecalciferol 150,000 IU by mouth every 2 months for 1 year | Dietary supplement | Vitamin D (cholecalciferol) |
| Placeboplacebo by mouth every 2 months for 1 year | Dietary supplement | Placebo |
Primary outcome
To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml.
Time frame: 1 year
To see if raising the serum 25(OH) D levels reduces the incidence of cardiovascular events in patients with coronary artery disease (CAD).
Time frame: 1 year
4 secondary outcomes
To see if higher serum 25(OH) D levels will help in better control of blood pressure.
Time frame: 1 year
To perform proteomics analysis to: a) Extract total protein; b) Profile protein expression in 2-DE and /or 2-DLC and direct mass spectrometric analysis (dMS) on the serum of vitamin D supplemented and placebo subjects.
Time frame: 1 year
To compare protein expression profiles and/or MS spectrum pattern recognition, and identify differentially expressed proteins in vitamin D supplemented and placebo subjects.
Time frame: 1 year
To obtain bone mineral density measurements (by DXA) and assess bone markers in subjects with known coronary artery disease
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
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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.
Laura Armas, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Cardiovascular Disease, run by Creighton University at 2 sites 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To give oral vitamin D supplements and raise the blood levels of 25-OH D in the study subjects to >30ng/ml. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 15 Jan 2016.