Recruiting

Vitamin D with Tekturna

Sponsor:

Wayne State University

Code:

NCT01472796

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Vitamin D (cholecalciferol)

Tekturna(Aliskiren) plus placebo

Study Details

Brief summary:

In this research study, the goal is to find out if a currently FDA-approved medication called Tekturna(Aliskiren) along with the addition of Vitamin D will lower blood pressure and improve heart function in the African American population. High blood pressure occurs earlier in life in African Americans, is more severe, and is associated with greater organ damage in relation to uncontrolled hypertension. Having low levels of Vitamin D is also very common in the African American population. Research has shown that there may be a link between low Vitamin D levels and the ability of high blood pressure medications to be fully effective.

Conditions

Hypertension

Study ID

NCT01472796

Start date

Jul, 2011

Status verified date

Nov, 2011

Completion date

Mar, 2014

Anticipated

Primary completion date

Jul, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 30-74
  • Systolic Blood Pressure 140-159 mm Hg and Diastolic Blood Pressure <100 OR Diastolic Blood Pressure 90-99mm Hg and Systolic Blood Pressure <160mm Hg
  • Vitamin D deficiency: Serum 25-OH D >= 10 ng/ml (25 nmol/L) to < 20 ng/ml (50 nmol/L)
  • Not using any antihypertensive medication(s) for the previous 3 months

Exclusion Criteria:

  • Cancer(other than skin) known HIV or other medical condition that might limit life expectancy.
  • Pregnant or nursing
  • Know adverse reactions to DRI's
  • Hepatitis or liver enzyme elevations > 1.5x normal
  • Estimated glomerular filtration rate (EGFR) <50 ml/min/1.7m2
  • Diabetes Mellitus
  • Serum calcium > 10.5 mg/dl or history of hypercalcemia
  • History of primary hyperparathyroidism
  • Sarcoidosis or other granulomatous disease
  • Taking > 500 mg/d of supplemental elemental calcium
  • Taking any drugs that decrease absorption of vitamin D, ex:xenical
  • Taking the drug cyclosporine
  • Taking any antihypertensive medications in the previous 3 months
  • History of kidney stones
  • Planning to move > 50 miles in the next 9 months

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Tekturna (Aliskirin) with vit. D supplementation

Tekturna (Aliskiren) 300mg daily and vitamin D supplementation (50,000 IU)every other week.

placebo comparator: Tekturna (Aliskiren) with placebo

Tekturna (Aliskiren) 300mg per day supplemented with placebo (vitamin D)

Interventions

Vitamin D (cholecalciferol)

Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks

Tekturna(Aliskiren) plus placebo

Aliskiren 300 mg per day supplemented with placebo

Primary outcome measure

  • Change in Ambulatory Systolic Blood Pressure [ Time Frame: from baseline (Week 10) to Week 18 ]

Central Contacts and Locations

Central contacts

Carol A Muzyk, CCRP

313-745-2378cmuzyk@med.wayne.edu

Donna Ford

888-235-5467

Locations

Wayne State University, 4201 St. Antoine

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Carol A Muzyk, CCRP

313-745-2378cmuzyk@med.wayne.edu

Donna Ford

888-235-5467

Principal Investigator:

John M Flack, M.D., M.P.H.

More Information

Sponsor

Wayne State University

Last update posted

Nov 16, 2011

Last verified

Nov, 2011

Keywords

  • African American
  • Vitamin D deficient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2011-11-16.