Vitamin D DeficiencyNCT00948298
Effect of Vitamin D3 on Vascular Function
A study testing Vitamin D in people with Vitamin D Deficiency, run by Charles Drew University of Medicine and Science.
Trial summary
Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D. Vitamin D balances the calcium in our body. If our vitamin D levels get too low, it can cause health problems. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- 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
- 130 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Aug 2012
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18-70 years of age and self-identified as African-American or Black
- Hypertension
- If a potential study patient is not on treatment, their systolic blood pressure (SBP) must be > 130 mmHg, or diastolic blood pressure (DBP) > 85 mmHg, and SBP must be <160 mmHg and DBP must be < 105 mmHg.
- If a potential study patient is on treatment then the SBP must be <160 mmHg and DBP must be < 105 mmHg
- Screening Vitamin D (D2 and D3 level) between 10 and 25 ng/ml (normal level > 30 ng/ml)
- Body mass index (BMI) > 25 kg/m2
Who cannot join
- Poorly controlled high blood pressure (SBP >160 mmHg or DBP > 105 mmHg)
- Diabetes (fasting blood sugar > 125 mg/dl, or HbA1c > 6.5%)
- Screening Vitamin D (D2 and D3 level) < 10 ng/ml or > 25 ng/ml
- Estimated glomerular filtration rate (eGFR) < 45 ml/min
- Evidence of disease resulting in hypercalcemia
- History of kidney stones
Show all 14Show fewer
- History of drug, alcohol, or illicit substance abuse within the past 6 months
- History of another chronic disease which the investigator feels should preclude the subject from entering the study
- Liver function tests (LFTs) greater than twice the upper limit of normal
- Subjects requiring chronic use of nonsteroidal anti-inflammatory drugs, aspirin, or other drugs that may affect the measurement of reactive oxidative species
- Subjects requiring treatment with other vitamin D preparations containing more than 400 IU of vitamin D
- Subjects requiring chronic use of immunosuppressive therapy or corticosteroids
- Recent (< 6 months) myocardial infarction, stroke, or hospitalization for congestive heart failure
- Allergy/intolerance: known allergy to oral vitamin D or microcrystalline cellulose
About this study
Official title: The Effect of Cholecalciferol (Vitamin D3) on Vascular Function and Cardiovascular Risk Factors
Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D. Vitamin D balances the calcium in our body. If our vitamin D levels get too low, it can cause health problems. It may increase our chance of getting high blood pressure or diabetes. Another problem we may have if our vitamin D levels are low is that our blood vessels may not work normally. These are important health problems for anyone. Because African Americans have darker skin, they are more likely than most other racial/ethnic groups to have low vitamin D levels. This study will look at treating African Americans with low vitamin D levels.
The goal of this study is to see how vitamin D helps blood vessels work. The investigators will do this study in African Americans who are overweight, have high blood pressure and have low vitamin D levels. The investigators will see if getting the vitamin D level to a normal value will improve how blood vessels work. The dose of vitamin D that will be given in this study is a high dose that is given to people with low vitamin D levels.
Read the detailed description
Cardiovascular Disease (CVD) and related disorders remain the leading cause of death in the nation. Hypovitaminosis D has been linked not only to several cardiovascular (CV) risk factors including hypertension, diabetes, obesity but also to increased rates of CVD. Thus,hypovitaminosis D presents a common pathway for a select subgroup with a clustering of CV risk factors in a profile that is predominant among ethnic minorities. Indeed, hypovitaminosis D is highly prevalent with an estimated 55% of the US adult population having levels at or below 30 ng/ml, and over 80% of African Americans having suboptimal values. Thus, we propose a twelve week randomized double-blind, placebo controlled pilot trial to assess the effect on vascular function and CV risk factors of 100,000 IU Vitamin D3 given every 4 weeks to overweight, hypertensive African-Americans with hypovitaminosis D. To our knowledge, the proposed project is the first to assess the effect of 'high-dose' Vitamin D3 administration on vascular function.We believe this study is also the first to examine the impact at a molecular level of Vitamin D3 repletion on the key mediators of cardio-metabolic pathways in humans. If our study results support our working hypothesis, we will be positioned to propose a larger scale study to detect a therapeutic effect on more definitive, clinical cardiovascular endpoints across a more diverse population.
Objectives:
- Assess the role of Vitamin D3 treatment on vascular function in high risk subjects.
Primary Outcome: The primary outcome variable is pulse wave velocity (PWV, unit - m/s) for vascular stiffness assessed by radial artery tonometry (via SphygmoCor). The hypothesis for the primary analysis is that a greater increase in the PWV will occur in the Vitamin D3 treatment group than in the placebo group.
Secondary Outcome: Vascular/endothelial function as determined by measuring non-invasive vascular finger plethysmography (via EndoPat). Additional surrogates to be assessed as secondary markers of vascular/endothelial function include sitting and 24 hour ambulatory blood pressure measurements and spot urine protein/creatinine ratio.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D, Placebo
- Keywords
- cardiovascular disease, vitamin D, african american, low vitamin D levels
- Medical subject headings
- Vitamin D Deficiency, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
PlaceboDrug
Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Vitamin D | Experimental | Not described Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity for Vascular Stiffness
The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.
Measured: 12 Weeks
Secondary outcomes (1)
Changes in Sitting and 24 Ambulatory Blood Pressure
Improved vascular function as determined by measuring sitting and 24 Hour Ambulatory Blood Pressure.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionAug 2012
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 Vitamin D DeficiencyStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, David Martins, Charles Drew University of Medicine and Science
- Investigators
- David Martins, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948298
- Sponsor's protocol ID
- IRB#08-05-2170-01
- Other IDs
- U54RR022762
- Status last verified
- Jun 2018
- First submitted
- 28 Jul 2009
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cholecalciferol (Vitamin D3) on Vascular Function and Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00948298
- Acronym / sponsor ID
- IRB#08-05-2170-01
- Conditions
- Vitamin D Deficiency
- Keywords
- cardiovascular disease, vitamin D, african american, low vitamin D levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D. Vitamin D balances the calcium in our body. If our vitamin D levels get too low, it can cause health problems. It may increase our chance of getting high blood pressure or diabetes. Another problem we may have if our vitamin D levels are low is that our blood vessels may not work normally. These are important health problems for anyone. Because African Americans have darker skin, they are more likely than most other racial/ethnic groups to have low vitamin D levels. This study will look at treating African Americans with low vitamin D levels.
The goal of this study is to see how vitamin D helps blood vessels work. The investigators will do this study in African Americans who are overweight, have high blood pressure and have low vitamin D levels. The investigators will see if getting the vitamin D level to a normal value will improve how blood vessels work. The dose of vitamin D that will be given in this study is a high dose that is given to people with low vitamin D levels.
Detailed description
Cardiovascular Disease (CVD) and related disorders remain the leading cause of death in the nation. Hypovitaminosis D has been linked not only to several cardiovascular (CV) risk factors including hypertension, diabetes, obesity but also to increased rates of CVD. Thus,hypovitaminosis D presents a common pathway for a select subgroup with a clustering of CV risk factors in a profile that is predominant among ethnic minorities. Indeed, hypovitaminosis D is highly prevalent with an estimated 55% of the US adult population having levels at or below 30 ng/ml, and over 80% of African Americans having suboptimal values. Thus, we propose a twelve week randomized double-blind, placebo controlled pilot trial to assess the effect on vascular function and CV risk factors of 100,000 IU Vitamin D3 given every 4 weeks to overweight, hypertensive African-Americans with hypovitaminosis D. To our knowledge, the proposed project is the first to assess the effect of 'high-dose' Vitamin D3 administration on vascular function.We believe this study is also the first to examine the impact at a molecular level of Vitamin D3 repletion on the key mediators of cardio-metabolic pathways in humans. If our study results support our working hypothesis, we will be positioned to propose a larger scale study to detect a therapeutic effect on more definitive, clinical cardiovascular endpoints across a more diverse population.
Objectives:
- Assess the role of Vitamin D3 treatment on vascular function in high risk subjects.
Primary Outcome: The primary outcome variable is pulse wave velocity (PWV, unit - m/s) for vascular stiffness assessed by radial artery tonometry (via SphygmoCor). The hypothesis for the primary analysis is that a greater increase in the PWV will occur in the Vitamin D3 treatment group than in the placebo group.
Secondary Outcome: Vascular/endothelial function as determined by measuring non-invasive vascular finger plethysmography (via EndoPat). Additional surrogates to be assessed as secondary markers of vascular/endothelial function include sitting and 24 hour ambulatory blood pressure measurements and spot urine protein/creatinine ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Vitamin D | Experimental | Drug: Vitamin D |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females, 18-70 years of age and self-identified as African-American or Black
- Hypertension
- If a potential study patient is not on treatment, their systolic blood pressure (SBP) must be > 130 mmHg, or diastolic blood pressure (DBP) > 85 mmHg, and SBP must be <160 mmHg and DBP must be < 105 mmHg.
- If a potential study patient is on treatment then the SBP must be <160 mmHg and DBP must be < 105 mmHg
- Screening Vitamin D (D2 and D3 level) between 10 and 25 ng/ml (normal level > 30 ng/ml)
Key exclusion criteria (14 listed)
- Poorly controlled high blood pressure (SBP >160 mmHg or DBP > 105 mmHg)
- Diabetes (fasting blood sugar > 125 mg/dl, or HbA1c > 6.5%)
- Screening Vitamin D (D2 and D3 level) < 10 ng/ml or > 25 ng/ml
- Estimated glomerular filtration rate (eGFR) < 45 ml/min
- Evidence of disease resulting in hypercalcemia
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 DTwo 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks. | Drug | Vitamin D |
| PlaceboTwo tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks. | Drug | Placebo |
Primary outcome
Pulse Wave Velocity for Vascular Stiffness
Time frame: 12 Weeks
The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.
1 secondary outcome
Changes in Sitting and 24 Ambulatory Blood Pressure
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- 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 Martins, MD principal investigator
Charles Drew University of Medicine and Science
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency, run by Charles Drew University of Medicine and Science.
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 6 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 17 Jul 2018). 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?
Pulse Wave Velocity for Vascular Stiffness (time frame: 12 Weeks). 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 Jul 2018.