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Vitamin D Deficiency in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00974922
Recruitment Status : Terminated (Administrative/Sponsor Business Decision - terminated - study was not completed)
First Posted : September 11, 2009
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
William B. White, UConn Health

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Hypertension Drug: Aliskiren Dietary Supplement: Cholecalciferol Dietary Supplement: Placebo Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension
Study Start Date : August 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Phase I: Aliskiren
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
Drug: Aliskiren
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
Other Name: Tekturna
Dietary Supplement: Placebo
Placebo for two weeks
Active Comparator: Phase I: Cholecalciferol
Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks
Dietary Supplement: Cholecalciferol
3000 I.U. once daily for 6 weeks
Other Name: Vitamin D3
Dietary Supplement: Placebo
Placebo for two weeks
Active Comparator: Phase II: Aliskiren and Vitamin D3
Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks
Drug: Aliskiren
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
Other Name: Tekturna
Dietary Supplement: Cholecalciferol
3000 I.U. once daily for 6 weeks
Other Name: Vitamin D3



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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. [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974922


Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Novartis
Investigators
Principal Investigator: William B White, M.D. Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center

Responsible Party: William B. White, Professor of Medicine, UConn Health
ClinicalTrials.gov Identifier: NCT00974922     History of Changes
Other Study ID Numbers: 09-166-1
20090713 ( Other Identifier: UConn Health Center )
First Posted: September 11, 2009    Key Record Dates
Results First Posted: March 9, 2018
Last Update Posted: March 9, 2018
Last Verified: February 2018

Keywords provided by William B. White, UConn Health:
Vitamin D
Hypertension

Additional relevant MeSH terms:
Hypertension
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents