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Effects of Vitamin D on Renin Expression in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00585442
First received: December 22, 2007
Last updated: July 28, 2011
Last verified: July 2011
History of Changes
  Purpose

The cardiovascular effects of vitamin D therapy (in humans) have been documented only in patients with known vitamin D deficiency or hyperparathyroidism (a surrogate marker of inadequate vitamin D activity). It is unknown whether the cardiovascular benefits of vitamin D therapy extend beyond these patients to the general hypertensive population. We propose to directly measure the effect of vitamin D therapy on plasma renin activity (PRA), plasma renin concentration (PRC), renin transcription (in mononuclear leukocytes), and blood pressure in hypertensive (but otherwise healthy) patients in a randomized, controlled, experimental trial. This will be the first study to assess vitamin D receptor (VDR) biological (PRA, PRC, renin mRNA, and polymorphisms) and hypertensive activity in patients without vitamin D deficiency. We hypothesize that vitamin D inhibition of renin transcription will produce significant reductions in PRA, PRC, renin transcription, inflammatory cytokines, SBP, and DBP, with potential variation by VDR genotype. Such a result may prove to be significant in the treatment of hypertension, as even modest blood pressure reductions (5 mmHg) are associated with a 14% reduction in mortality due to stroke, a 9% reduction in mortality due to CHD, and a 7% overall reduction in all-cause mortality.


Condition Intervention
Hypertension
Vitamin D Deficiency
 Drug: calcitriol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Calcitriol (1α, 25-[OH]2 Vitamin D3) on Renin Expression in Hypertensive Patients Without Vitamin D Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Compare plasma renin activity (PRA) and plasma renin concentration (PRC) in hypertensive patients (JNC VII stage I) following 14 days treatment with calcitriol (1α, 25-[OH]2 vitamin D3) or matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ] [ Designated as safety issue: No ]
Enrollment: 6
Study Start Date: May 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: calcitriol
1.0 mcg daily
Other Names:
  • Rocaltrol
  • 1α, 25-[OH]2 Vitamin D3

  Eligibility
Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients age > 55 years.
  2. Female patients must be postmenopausal, as determined by surgical hysterectomy or 12 month history since last active menstruation
  3. Stage I hypertension (JNC VII Criteria): mean systolic blood pressure (mSBP) 140-159 mmHg and mean diastolic blood pressure 90 - 99 mmHg (mDBP)2
  4. Provide informed consent

Exclusion Criteria:

  1. Serum vitamin D <55 pmol/L
  2. Serum calcium >10.5 mg/dL
  3. Serum phosphate (inorganic) >5.5 mg/dL
  4. Serum parathyroid hormone (PTH) >1.3 pmol/L
  5. Vitamin D supplements, calcium supplements, estrogen replacement therapy, corticosteroids (inhaled/oral), or hydroxymethyl glutarate CoA reductase inhibitors (statins) within 30 days prior to randomization
  6. Stage II hypertension (JNC VII criteria): mSSBP >160 mmHg or mSDBP >100 mmHg
  7. Use of alpha2-agonists, beta-blockers, or more than 2 anti-hypertensive medications at screening
  8. Estimated creatinine clearance <30 mL/min by Crockroft-Gault Formula
  9. History of heart failure (HF), acute myocardial infarction (AMI), acute coronary syndrome (ACS), transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral vascular disease (PVD), or known clotting disorder
  10. Insulin dependent diabetes mellitus (patients stabilized on oral regimens may be enrolled)
  11. History of hypersensitivity reaction to 1α, 25-(OH)2 vitamin D3 (calcitriol)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585442

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Mark Munger, PharmD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah, Univerisity of Utah
ClinicalTrials.gov Identifier: NCT00585442     History of Changes
Other Study ID Numbers: 22714, 10151812
Study First Received: December 22, 2007
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on March 03, 2015