HypertensionNCT00459563
Vitamin D and Blood Pressure
A study testing Vitamin D and calcitriol in people with Hypertension, run by Atlanta VA Medical Center at 1 site in United States.
Trial summary
Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Vitamin D and calcitriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2011
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be over the age of 18
- Vitamin D levels between 10 and 30 ng/ml
- Systolic blood pressure between 130 and 150 mmHg
Who cannot join
- Current use of anti-hypertensive medication
- Inability to understand the consent form
- Inability to return ABP monitor within 24-48 hours after visit
- Alcohol dependence
- Diagnosis of chronic kidney disease
- History of heart disease
Show all 12Show fewer
- History of stroke
- Inability to comply with study protocol
- Current treatment for cancer
- Narcotic dependence
- Current use of greater than 2000 IU of vitamin D
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-controlled Double Blinded Trial to Evaluate Cholecalciferol (Vitamin D3) and Calcitriol Treatment on Reducing Blood Pressure in Middle Aged Adults With Stage I Hypertension and Vitamin D Deficiency
Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.
- Conditions
- Hypertension
- Being tested
- Vitamin D, calcitriol, Placebo
- Keywords
- vitamin D, blood pressure, hypertension, Vitamin D insufficient, Systolic blood pressure between 130 and 150 mmHg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
200,000 IU once weekly for 3 weeks (600,000 IU total dose)
calcitriolDrug
calcitriol 0.5 mcg twice a day for 1 week
PlaceboDrug
Placebo once a week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cholecalciferol | Active comparator | Cholecalciferol Receives: Drug: Vitamin D |
| Calcitriol | Active comparator | Calcitriol Receives: Drug: calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 3 Weeks
25(OH)D
Measured: 3 weeks
Secondary outcomes (4)
Parathyroid hormone
Measured: 3 weeks
Renin
Measured: 3 weeks
Aldosterone
Measured: 3 weeks
Angiotensin II
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Vin Tangpricha, Atlanta VA Medical Center
- Investigators
- Vin Tangpricha, MD/PhD, Principal investigator, Emory University/VAMCSuzanne E Judd, MPH, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459563
- Sponsor's protocol ID
- 648-2006
- Other IDs
- VAMC Atlanta R&D AREF 283001
- Status last verified
- Jan 2014
- First submitted
- 10 Apr 2007
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Double Blinded Trial to Evaluate Cholecalciferol (Vitamin D3) and Calcitriol Treatment on Reducing Blood Pressure in Middle Aged Adults With Stage I Hypertension and Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT00459563
- Acronym / sponsor ID
- 648-2006
- Conditions
- Hypertension
- Keywords
- vitamin D, blood pressure, hypertension, Vitamin D insufficient, Systolic blood pressure between 130 and 150 mmHg
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Collaborators
- Emory University
- Study start
- Mar 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Apr 2007 (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.
Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cholecalciferol | Active comparator | Drug: Vitamin DCholecalciferol |
| Calcitriol | Active comparator | Drug: calcitriolCalcitriol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be over the age of 18
- Vitamin D levels between 10 and 30 ng/ml
- Systolic blood pressure between 130 and 150 mmHg
Key exclusion criteria (12 listed)
- Current use of anti-hypertensive medication
- Inability to understand the consent form
- Inability to return ABP monitor within 24-48 hours after visit
- Alcohol dependence
- Diagnosis of chronic kidney disease
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 D200,000 IU once weekly for 3 weeks (600,000 IU total dose) | Drug | Cholecalciferol |
| calcitriolcalcitriol 0.5 mcg twice a day for 1 week | Drug | Calcitriol |
| PlaceboPlacebo once a week for 3 weeks | Drug | Placebo |
Primary outcome
Blood pressure
Time frame: 3 Weeks
25(OH)D
Time frame: 3 weeks
4 secondary outcomes
Parathyroid hormone
Time frame: 3 weeks
Renin
Time frame: 3 weeks
Aldosterone
Time frame: 3 weeks
Angiotensin II
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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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.
Vin Tangpricha, MD/PhD principal investigator
Emory University/VAMC
Suzanne E Judd, MPH study director
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and calcitriol in people with Hypertension, run by Atlanta VA Medical Center 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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 8 Jan 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood pressure (time frame: 3 Weeks). 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 8 Jan 2014.