Vitamin D Deficiency in Patients With Hypertension

• Sponsor: UConn Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00974922
• Collaborator: Novartis (Industry)
• Enrollment: 40
• Location: 1
• Arms: 3
• Duration (Months): 28
• Patients Per Site Per Month: 1.4

Study Details

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.

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 Design

• Study Type: Interventional
• 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: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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: Cholecalciferol; 3000 I.U. once daily for 6 weeks; Other Names: 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 Names: Tekturna ; Dietary Supplement: Cholecalciferol; 3000 I.U. once daily for 6 weeks; Other Names: Vitamin D3

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Ambulatory Diastolic Blood Pressure [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. [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William B. White, Professor of Medicine, UConn Health
• ClinicalTrials.gov Identifier: NCT00974922
• Other Study ID Numbers: 09-166-1; 20090713
• First Posted: Sep 11, 2009
• Last Update Posted: Mar 9, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by William B. White, Professor of Medicine, UConn Health: Vitamin D; Hypertension
• Additional relevant MeSH terms: Hypertension; Vitamin D Deficiency; Vitamin D; Cholecalciferol

Study Results

Participant Flow

Recruitment Details	Study initiated in 2010, study terminated prematurely by the sponsor in December 2011.

Arm/Group Title	Aliskiren and Vitamin D3 AND Aliskiren Versus Vitamin D3
Arm/Group Description	Study stopped prematurely. Intervention groups combined because data were never unblinded.
Period Title: Overall Study
STARTED	40
COMPLETED	16
NOT COMPLETED	24

Baseline Characteristics

Arm/Group Title	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Arm/Group Description	Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	36 90%
>=65 years	4 10%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.85 (11.3)
Sex: Female, Male (Count of Participants)
Female	25 62.5%
Male	15 37.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.

Arm/Group Title	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Arm/Group Description	Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.

Arm/Group Title	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Arm/Group Description	Phase I: Two weeks of single-blind placebo, followed by randomization in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.
Measure Participants	0

Adverse Events

Time Frame	Adverse event data were collected throughout the duration of the study ~ 2 years, 6 months
Adverse Event Reporting Description	Data not analyzed by groups as group assignment was blinded (and never un-blinded due to discontinuation by the sponsor).
Arm/Group Title	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
Arm/Group Description	Phase I: Two weeks of single-blind placebo, followed by randomized in a double-blind fashion to aliskiren 150 mg to 300 mg or Vitamin D3 (3000 I.U.) once daily for 6 weeks. Phase II: Aliskiren 150-300 mg orally once daily and Vitamin D3 3000 IU in combination once daily for 6 weeks.
All Cause Mortality
	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Aliskiren Versus Vitamin D3 AND Aliskiren and Vitamin D3
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

Study was never completed due to early termination of the trial by sponsor. Data were never analyzed because group assignment was never un-blinded and data lacked any scientific utility.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.