Vitamin D Deficiency in Patients With Hypertension

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Collaborator: Novartis
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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