Vitamin D Deficiency in Patients With Hypertension

Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Vitamin D Deficiency
• Intervention / Treatment: Drug: Aliskiren; Dietary supplement: Placebo; Dietary supplement: Cholecalciferol

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
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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: Placebo; Placebo for two weeks; Dietary supplement: Cholecalciferol; 3000 I.U. once daily for 6 weeks; Other Names: Vitamin D3
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 Names: Tekturna; Dietary supplement: Cholecalciferol; 3000 I.U. once daily for 6 weeks; Other Names: Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Novartis
• Investigators: Principal Investigator: William B White, M.D., Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (Estimate): September 11, 2009

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Vitamin D; Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Hypertension; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 09-166-1; 20090713 (Other Identifier: UConn Health Center)