Vitamin D DeficiencyPhase 4NCT00974922
Vitamin D Deficiency in Patients With Hypertension
A Phase 4 study testing Aliskiren and Cholecalciferol in people with Vitamin D Deficiency and Hypertension, run by UConn Health at 1 site in United States.
Trial summary
This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Vitamin D Deficiency, Hypertension
- What is being tested?
- Aliskiren and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2011
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined as a seated diastolic BP ≥ 90 mmHg and < 110 mmHg in the untreated state).
- Patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
- 25-hydroxyvitamin D levels < 30 ng/ml and > 12 ng/ml.
- Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.
Who cannot join
- Vitamin D levels < 12 ng/ml
- Known hypersensitivity or allergy to aliskiren
- Clinic blood pressure > 180/110 mmHg
- Known forms of secondary hypertension
- Chronic atrial fibrillation
- Uncontrolled or unstable cardiovascular diseases
Show all 10Show fewer
- Shift or night workers
- Mid-arm circumference > 42 cm in diameter
- Current or recent (<1 year) alcohol or drug abuse
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension
This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
Read the detailed description
This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.
- Conditions
- Vitamin D Deficiency, Hypertension
- Being tested
- Aliskiren, Cholecalciferol, Placebo
- Keywords
- Vitamin D, Hypertension
- Medical subject headings
- Vitamin D Deficiency, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Tekturna
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
CholecalciferolDietary supplement
Also called Vitamin D3
3000 I.U. once daily for 6 weeks
PlaceboDietary supplement
Placebo for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Aliskiren | Active comparator | Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Aliskiren 150 mg to 300 mg once daily for 6 weeks Receives: Drug: Aliskiren; Dietary Supplement: Placebo |
| Phase I: Cholecalciferol | Active comparator | Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks Receives: Dietary Supplement: Cholecalciferol; Dietary Supplement: Placebo |
| Phase II: Aliskiren and Vitamin D3 | Active comparator | Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks Receives: Drug: Aliskiren; Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Ambulatory Diastolic Blood Pressure
The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency.
Measured: six weeks
Secondary outcomes (1)
Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Administrative/Sponsor Business Decision - terminated - study was not completed
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, William B. White, UConn Health
- Investigators
- William B White, M.D., Principal investigator, Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974922
- Sponsor's protocol ID
- 09-166-1
- Other IDs
- 20090713
- Status last verified
- Feb 2018
- First submitted
- 10 Sep 2009
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT00974922
- Acronym / sponsor ID
- 09-166-1
- Conditions
- Vitamin D Deficiency, Hypertension
- Keywords
- Vitamin D, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative/Sponsor Business Decision - terminated - study was not completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.
Detailed description
This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I: Aliskiren | Active comparator | Drug: Aliskiren, Dietary Supplement: PlaceboTwo weeks of single-blind placebo, followed by randomization in a double-blind fashion to Aliskiren 150 mg to 300 mg once daily for 6 weeks |
| Phase I: Cholecalciferol | Active comparator | Dietary Supplement: Cholecalciferol, Dietary Supplement: PlaceboTwo weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks |
| Phase II: Aliskiren and Vitamin D3 | Active comparator | Drug: Aliskiren, Dietary Supplement: CholecalciferolAliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined as a seated diastolic BP ≥ 90 mmHg and < 110 mmHg in the untreated state).
- Patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
- 25-hydroxyvitamin D levels < 30 ng/ml and > 12 ng/ml.
- Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.
Key exclusion criteria (10 listed)
- Vitamin D levels < 12 ng/ml
- Known hypersensitivity or allergy to aliskiren
- Clinic blood pressure > 180/110 mmHg
- Known forms of secondary hypertension
- Chronic atrial fibrillation
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 |
|---|---|---|
| AliskirenAlso: Tekturna150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks | Drug | Phase I: Aliskiren, Phase II: Aliskiren and Vitamin D3 |
| CholecalciferolAlso: Vitamin D33000 I.U. once daily for 6 weeks | Dietary supplement | Phase I: Cholecalciferol, Phase II: Aliskiren and Vitamin D3 |
| PlaceboPlacebo for two weeks | Dietary supplement | Phase I: Aliskiren, Phase I: Cholecalciferol |
Primary outcome
Change From Baseline in Ambulatory Diastolic Blood Pressure
Time frame: six weeks
The primary endpoint was changes from baseline in 24-hour mean diastolic BP on aliskiren versus vitamin D3 in hypertensive patients with vitamin D deficiency.
1 secondary outcome
Change From Baseline Blood Pressure Measurement in 24-hour Systolic BP, Changes in Awake and Sleep Systolic and Diastolic BP, and Changes From Baseline in Clinic Systolic and Diastolic BP.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
William B White, M.D. principal investigator
Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aliskiren and Cholecalciferol in people with Vitamin D Deficiency and Hypertension, run by UConn Health 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 4 inclusion and 10 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 9 Mar 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Mar 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?
Change From Baseline in Ambulatory Diastolic Blood Pressure (time frame: six 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 9 Mar 2018.