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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 19, 2013