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Vitamin D Deficiency in Patients With Hypertension

Primary Purpose

Vitamin D Deficiency, Hypertension

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aliskiren
Cholecalciferol
Placebo
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Hypertension

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Phase I: Aliskiren

Phase I: Cholecalciferol

Phase II: Aliskiren and Vitamin D3

Arm Description

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

Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks

Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks

Outcomes

Primary Outcome Measures

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.

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.

Full Information

First Posted
September 10, 2009
Last Updated
February 9, 2018
Sponsor
UConn Health
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00974922
Brief Title
Vitamin D Deficiency in Patients With Hypertension
Official Title
Vitamin D Deficiency, Renin Inhibitor Response, and Vitamin D Supplementation in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Administrative/Sponsor Business Decision - terminated - study was not completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Hypertension
Keywords
Vitamin D, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase I: Aliskiren
Arm Type
Active Comparator
Arm Description
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
Arm Title
Phase I: Cholecalciferol
Arm Type
Active Comparator
Arm Description
Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to Cholecalciferol (3000 I.U.) once daily for 6 weeks
Arm Title
Phase II: Aliskiren and Vitamin D3
Arm Type
Active Comparator
Arm Description
Aliskiren 150-300 mg orally once daily and Cholecalciferol 3000 I.U. in combination once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Tekturna
Intervention Description
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
3000 I.U. once daily for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for two weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Ambulatory Diastolic Blood Pressure
Description
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William B White, M.D.
Organizational Affiliation
Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Vitamin D Deficiency in Patients With Hypertension

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