Hypertension, Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Hypertension
Brief 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. 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.
Interventions
DRUGAliskiren
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
DIETARY_SUPPLEMENTCholecalciferol
3000 I.U. once daily for 6 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo for two weeks
Sponsors
Novartis
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Shift or night workers * Mid-arm circumference \> 42 cm in diameter * Current or recent (\<1 year) alcohol or drug abuse * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ambulatory Diastolic Blood Pressure | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 6 weeks |
Countries
United States
Participant flow
Recruitment details
Study initiated in 2010, study terminated prematurely by the sponsor in December 2011.
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3 Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.
Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated | 24 |
Baseline characteristics
| Characteristic | Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Age, Continuous | 54.85 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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.
Time frame: six weeks
Population: Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.
Secondary
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
Population: Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.