Cardiovascular DiseasesEarly Phase 1CVD CookieNCT01049048
The Effect of Vitamin D Statues on Endothelial Function
A Early Phase 1 study testing Vitamin D3 in people with Cardiovascular Diseases and Vitamin D Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2010
- Phase
- Early Phase 1
- 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 55 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, community-dwelling ambulatory post-menopausal women.
- Able and willing to sign informed consent.
- Ages: 55-65.
- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml
- Not pregnant
- Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed.
- Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected.
- Willing to fast for 12 hours.
Who cannot join
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- History of nephrolithiasis
- Baseline 24-hour urine calcium > 250 mg
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.
- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.
- Known previous personal history of cardiovascular disease.
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- Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 25 ml/minute.
- Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.
- Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital.
- Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc.
- Known allergy to chocolate.
- Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, parathyroid hormone, testosterone or calcitonin.
- Treatment with any active metabolites of vitamin D, e.g., calcitriol, within six months of screening.
- Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Osteoporosis Clinical and Research Program
Madison, Wisconsin, 53705
About this study
In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction. Moreover, we hypothesize that vitamin D supplementation will restore endothelial function, thereby reducing cardiovascular disease risk.
This pilot research will be conducted in 64 post-menopausal women participating in an existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the others matching placebo) and will explore the effects of vitamin D on endothelial function and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their highest risk for development of a subsequent new cardiovascular disease diagnosis. All study participants will have fasting laboratory and noninvasive vascular ultrasound studies performed at baseline and four months later. The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. If our hypotheses are correct, our long-term goals include investigation of the effect of vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.
- Conditions
- Cardiovascular Diseases, Vitamin D Deficiency
- Being tested
- Vitamin D3, Placebo
- Keywords
- Endothelial Function, Arterial stiffness, Vitamin D
- Medical subject headings
- Cardiovascular Diseases, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
2500 IU Vitamin D3
PlaceboDietary supplement
No (0 IU) vitamin D3 added to cookie.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | This group receives placebo chocolate cookies with no vitamin D3 added. Receives: Dietary Supplement: Placebo |
| Vitamin D3 | Experimental | This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rekha Ramamurthy, M.D., Principal investigator, University of Wisconsin Osteoporosis Clinical Center and Research ProgramNeil C Binkley, M.D., Study director, University of Wisconsin Osteoporosis Clinical Center and Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049048
- Sponsor's protocol ID
- H-2008-0190
- Acronym
- CVD Cookie
- Status last verified
- Mar 2011
- First submitted
- 12 Jan 2010
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.
PubMed 22586483
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Statues on Endothelial Function
- ClinicalTrials.gov ID
- NCT01049048
- Acronym / sponsor ID
- CVD Cookie / H-2008-0190
- Conditions
- Cardiovascular Diseases, Vitamin D Deficiency
- Keywords
- Endothelial Function, Arterial stiffness, Vitamin D
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Jan 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.
In the United States, cardiovascular disease causes over one-third of all deaths and vitamin D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction. Moreover, we hypothesize that vitamin D supplementation will restore endothelial function, thereby reducing cardiovascular disease risk.
This pilot research will be conducted in 64 post-menopausal women participating in an existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the others matching placebo) and will explore the effects of vitamin D on endothelial function and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their highest risk for development of a subsequent new cardiovascular disease diagnosis. All study participants will have fasting laboratory and noninvasive vascular ultrasound studies performed at baseline and four months later. The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. If our hypotheses are correct, our long-term goals include investigation of the effect of vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: PlaceboThis group receives placebo chocolate cookies with no vitamin D3 added. |
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3This group receives 2500 IU of Vitamin D3 added to a chocolate cookie daily. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy, community-dwelling ambulatory post-menopausal women.
- Able and willing to sign informed consent.
- Ages: 55-65.
- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml
- Not pregnant
Key exclusion criteria (14 listed)
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- History of nephrolithiasis
- Baseline 24-hour urine calcium > 250 mg
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.
- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.
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 D32500 IU Vitamin D3 | Dietary supplement | Vitamin D3 |
| PlaceboNo (0 IU) vitamin D3 added to cookie. | Dietary supplement | Control |
Primary outcome
The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
Time frame: 17 months
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 5 Oct 2015.
- Derived from this study: PubMed 22586483Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.
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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.
Rekha Ramamurthy, M.D. principal investigator
University of Wisconsin Osteoporosis Clinical Center and Research Program
Neil C Binkley, M.D. study director
University of Wisconsin Osteoporosis Clinical Center and Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin D3 in people with Cardiovascular Diseases and Vitamin D Deficiency, run by University of Wisconsin, Madison 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 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 5 Oct 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 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?
The primary outcome measure of this pilot study is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy. (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049048, which also lists 1 linked publication.
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 5 Oct 2015.