Vitamin D Deficiency in Patients With Hypertension

This study has been terminated.
(Administrative/Sponsor Business Decision)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
William B. White, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00974922
First received: September 10, 2009
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Vitamin D Deficiency
Hypertension
Drug: aliskiren (Tekturna)
Dietary Supplement: cholecalciferol (Vitamin D3)
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Change in the baseline blood pressure measurement in 24-hour mean diastolic blood pressure. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Phase 1
Two weeks of single-blind placebo, then randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks.
Drug: aliskiren (Tekturna)
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
Other Name: Tekturna
Dietary Supplement: cholecalciferol (Vitamin D3)
3,000 I.U. once daily for 6 weeks.
Other Name: Vitamin D3
Dietary Supplement: Placebo
Placebo
Active Comparator: Phase 2
Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.
Drug: aliskiren (Tekturna)
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
Other Name: Tekturna
Dietary Supplement: cholecalciferol (Vitamin D3)
3,000 I.U. once daily for 6 weeks.
Other Name: Vitamin D3

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974922

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

No publications provided

Responsible Party: William B. White, Professor of Medicine, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00974922     History of Changes
Other Study ID Numbers: 091661, 20090713
Study First Received: September 10, 2009
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Vitamin D
Hypertension

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

ClinicalTrials.gov processed this record on August 28, 2014