Vitamin D Deficiency in Patients With Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00974922
• Other study ID #: 09-166-1
• Secondary ID: 20090713
• Status: Terminated
• Phase: Phase 4
• First received: September 10, 2009
• Last updated: February 9, 2018
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2018
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Vitamin D Deficiency

Intervention

Drug:
• Aliskiren
150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks

Dietary Supplement:
• Cholecalciferol
3000 I.U. once daily for 6 weeks
• Placebo
Placebo for two weeks

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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