HypertensionPhase 4VDATHNCT01472796
Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension
A Phase 4 study testing Vitamin D (cholecalciferol) in people with Hypertension, run by Wayne State University at 1 site in United States.
Trial summary
In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Vitamin D (cholecalciferol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Mar 2014
- Phase
- Phase 4
- 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 30-74
- Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure <100 OR Diastolic Blood Pressure 90-99mm Hg and Systolic Blood Pressure <160mm Hg
- Vitamin D deficiency: Serum 25-OH D >= 10 ng/ml (25 nmol/L) to < 20 ng/ml (50 nmol/L)
- Not using any antihypertensive medication(s) for the previous 3 months
Who cannot join
- Cancer(other than skin) known HIV or other medical condition that might limit life expectancy.
- Pregnant or nursing
- Know adverse reactions to DRI's
- Hepatitis or liver enzyme elevations > 1.5x normal
- Estimated glomerular filtration rate (EGFR) <50 ml/min/1.7m2
- Diabetes Mellitus
Show all 15Show fewer
- Serum calcium > 10.5 mg/dl or history of hypercalcemia
- History of primary hyperparathyroidism
- Sarcoidosis or other granulomatous disease
- Taking > 500 mg/d of supplemental elemental calcium
- Taking any drugs that decrease absorption of vitamin D, ex:xenical
- Taking the drug cyclosporine
- Taking any antihypertensive medications in the previous 3 months
- History of kidney stones
- Planning to move > 50 miles in the next 9 months
Trial locations and contacts
1 site in 1 country.
Donna Ford contact
United States1 site, 1 recruiting
- Recruiting
Wayne State University, 4201 St. Antoine
Detroit, Michigan, 48201
Carol A Muzyk, CCRP, 313-745-2378, cmuzyk@med.wayne.edu
Donna Ford, 888-235-5467
About this study
Official title: Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH)
In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.
Read the detailed description
The overarching hypothesis is that African Americans with hypertension have an overactive RAS (Renin Angiotensin System) in the body that is responsible for internally regulating blood pressure. Many blood pressure medications change regulation of the RAS system in order to keep blood pressure down. The purpose of this research study is to determine whether or not African American adults with hypertension have an overactive RAS system due to Vitamin D deficiency, resulting in the inability of the medication Tekturna to lower blood pressure. In this study, all participants will receive 300mg of Tekturna per day. Additionally half of the participants will randomly be selected to receive either 50,000 IU of Vitamin D (in its cholecalciferol form) orally once every other week or a vitamin D placebo once every other week. There will be 4 study visits over 18 weeks and follow up phone calls every two weeks for the duration of the study.
Specific Aims:
To demonstrate in African American Hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will lower blood pressure more than Tekturna + placebo.
To demonstrate in African American hypertensives consuming a calcium replete diet that albuminuria will be lowered more with Tekturna + Vitamin D versus Tekturna + placebo.
To demonstrate in African American hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will improve measures on non-invasively measured vascular function (peripheral vascular resistance, augmentation index, carotid-femoral pulse wave velocity and central aortic pressure) more than Tekturna + placebo.
- Conditions
- Hypertension
- Being tested
- Vitamin D (cholecalciferol), Tekturna(Aliskiren) plus placebo
- Keywords
- African American, Vitamin D deficient
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (cholecalciferol)Dietary supplement
Also called Tekturna (Aliskirin), cholecalciferol
Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks
Tekturna(Aliskiren) plus placeboDrug
Also called Tekturna (Aliskirin)
Aliskiren 300 mg per day supplemented with placebo
| Study group | Role | What they receive |
|---|---|---|
| Tekturna (Aliskirin) with vit. D supplementation | Active comparator | Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week. Receives: Dietary Supplement: Vitamin D (cholecalciferol) |
| Tekturna (Aliskiren) with placebo | Placebo comparator | Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D) Receives: Drug: Tekturna(Aliskiren) plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ambulatory Systolic Blood Pressure
Measured: from baseline (Week 10) to Week 18
Secondary outcomes (9)
Change in ambulatory diastolic blood pressure
Measured: from baseline (Week 10) to Week 18
Change in cuff systolic blood pressure
Measured: from baseline (Week 10) to Week 18
Change in cuff diastolic blood pressure
Measured: from baseline (week 10) to Week 18
Change in Urinary albumin:creatinine ratio
Measured: from baseline (week 10) to Week 18
Change in plasma isoprostanes
Measured: from baseline (week 10) to Week 18
Change in urinary nitric oxide metabolites
Measured: from baseline (week 10) to Week 18
Change in plasma renin activity
Measured: from baseline (week 10) to Week 18
Change in urinary angiotensinogen
Measured: from baseline (week 10) to Week 18
Change in non-invasively obtained measures of vascular function
Measured: from baseline (week 10) to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionMar 2014 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, John M. Flack, Wayne State University
- Investigators
- John M Flack, M.D., M.P.H., Principal investigator, Wayne State University, TRaCE Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472796
- Sponsor's protocol ID
- CSPP100AUS41T
- Acronym
- VDATH
- Status last verified
- Nov 2011
- First submitted
- 11 Nov 2011
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Augmentation of Tekturna (Aliskiren) in Hypertension (VDATH)
- ClinicalTrials.gov ID
- NCT01472796
- Acronym / sponsor ID
- VDATH / CSPP100AUS41T
- Conditions
- Hypertension
- Keywords
- African American, Vitamin D deficient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 16 Nov 2011 (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 this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.
Detailed description
The overarching hypothesis is that African Americans with hypertension have an overactive RAS (Renin Angiotensin System) in the body that is responsible for internally regulating blood pressure. Many blood pressure medications change regulation of the RAS system in order to keep blood pressure down. The purpose of this research study is to determine whether or not African American adults with hypertension have an overactive RAS system due to Vitamin D deficiency, resulting in the inability of the medication Tekturna to lower blood pressure. In this study, all participants will receive 300mg of Tekturna per day. Additionally half of the participants will randomly be selected to receive either 50,000 IU of Vitamin D (in its cholecalciferol form) orally once every other week or a vitamin D placebo once every other week. There will be 4 study visits over 18 weeks and follow up phone calls every two weeks for the duration of the study.
Specific Aims:
To demonstrate in African American Hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will lower blood pressure more than Tekturna + placebo.
To demonstrate in African American hypertensives consuming a calcium replete diet that albuminuria will be lowered more with Tekturna + Vitamin D versus Tekturna + placebo.
To demonstrate in African American hypertensives consuming a calcium replete diet that Tekturna + Vitamin D will improve measures on non-invasively measured vascular function (peripheral vascular resistance, augmentation index, carotid-femoral pulse wave velocity and central aortic pressure) more than Tekturna + placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tekturna (Aliskirin) with vit. D supplementation | Active comparator | Dietary Supplement: Vitamin D (cholecalciferol)Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week. |
| Tekturna (Aliskiren) with placebo | Placebo comparator | Drug: Tekturna(Aliskiren) plus placeboTekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D) |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 30-74
- Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure <100 OR Diastolic Blood Pressure 90-99mm Hg and Systolic Blood Pressure <160mm Hg
- Vitamin D deficiency: Serum 25-OH D >= 10 ng/ml (25 nmol/L) to < 20 ng/ml (50 nmol/L)
- Not using any antihypertensive medication(s) for the previous 3 months
Key exclusion criteria (15 listed)
- Cancer(other than skin) known HIV or other medical condition that might limit life expectancy.
- Pregnant or nursing
- Know adverse reactions to DRI's
- Hepatitis or liver enzyme elevations > 1.5x normal
- Estimated glomerular filtration rate (EGFR) <50 ml/min/1.7m2
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 D (cholecalciferol)Also: Tekturna (Aliskirin), cholecalciferolTekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks | Dietary supplement | Tekturna (Aliskirin) with vit. D supplementation |
| Tekturna(Aliskiren) plus placeboAlso: Tekturna (Aliskirin)Aliskiren 300 mg per day supplemented with placebo | Drug | Tekturna (Aliskiren) with placebo |
Primary outcome
Change in Ambulatory Systolic Blood Pressure
Time frame: from baseline (Week 10) to Week 18
9 secondary outcomes
Change in ambulatory diastolic blood pressure
Time frame: from baseline (Week 10) to Week 18
Change in cuff systolic blood pressure
Time frame: from baseline (Week 10) to Week 18
Change in cuff diastolic blood pressure
Time frame: from baseline (week 10) to Week 18
Change in Urinary albumin:creatinine ratio
Time frame: from baseline (week 10) to Week 18
Change in plasma isoprostanes
Time frame: from baseline (week 10) to Week 18
Change in urinary nitric oxide metabolites
Time frame: from baseline (week 10) to Week 18
Change in plasma renin activity
Time frame: from baseline (week 10) to Week 18
Change in urinary angiotensinogen
Time frame: from baseline (week 10) to Week 18
Change in non-invasively obtained measures of vascular function
Time frame: from baseline (week 10) to Week 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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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.
Donna Ford contact
John M Flack, M.D., M.P.H. principal investigator
Wayne State University, TRaCE Research Group
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 Vitamin D (cholecalciferol) in people with Hypertension, run by Wayne State University 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 15 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: status not confirmed, as of the sponsor's last update on 16 Nov 2011. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol A Muzyk, CCRP (313-745-2378, cmuzyk@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ambulatory Systolic Blood Pressure (time frame: from baseline (Week 10) to Week 18). 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 16 Nov 2011.