Vitamin D Deficiency in Patients With Hypertension

NCT00974922 | Terminated Phase 4 Results

• 2 other identifiers: 09-166-120090713
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Hypertension

Keywords

Vitamin D; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (3)

Phase I: Aliskiren

ACTIVE COMPARATOR

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; Dietary Supplement: Placebo

Phase I: Cholecalciferol

ACTIVE COMPARATOR

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; Dietary Supplement: Placebo

Phase II: Aliskiren and Vitamin D3

ACTIVE COMPARATOR

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

Drug: Aliskiren; Dietary Supplement: Cholecalciferol

Interventions

Aliskiren DRUG

150 mg once daily for 2 weeks, then titrated to 300 mg once daily for 4 weeks

Also known as: Tekturna

Phase I: Aliskiren; Phase II: Aliskiren and Vitamin D3

Cholecalciferol DIETARY_SUPPLEMENT

3000 I.U. once daily for 6 weeks

Also known as: Vitamin D3

Phase I: Cholecalciferol; Phase II: Aliskiren and Vitamin D3

Placebo DIETARY_SUPPLEMENT

Placebo for two weeks

Phase I: Aliskiren; Phase I: Cholecalciferol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Novartis: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Hypertension

Interventions

aliskiren; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and 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.

Results Point of Contact

• Title: Dr. William White
• Organization: UCHC

wwhite@uchc.edu

860-679-2104

Study Officials

• William B White, M.D.

  Pat and Jim Calhoun Cardiology Center, University of Connecticut Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 9, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-02

Locations

US (1)