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Effects of Vitamin D on Renin Expression in Hypertensive Patients

This study has been terminated.
(Lack of quality data)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585442
First Posted: January 3, 2008
Last Update Posted: May 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
mark munger, University of Utah
  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 Phase
Hypertension Vitamin D Deficiency Drug: calcitriol Drug: Placebo Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by mark munger, 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) ]

Secondary Outcome Measures:
  • Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ]

Enrollment: 12
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: Calcitriol Drug: calcitriol
1.0 mcg daily
Other Names:
  • Rocaltrol
  • 1α, 25-[OH]2 Vitamin D3
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: mark munger, Professor, Pharmacotherapy, University of Utah
ClinicalTrials.gov Identifier: NCT00585442     History of Changes
Other Study ID Numbers: 22714
10151812 ( Other Grant/Funding Number: American Foundation for Pharmaceutical Education )
First Submitted: December 22, 2007
First Posted: January 3, 2008
Last Update Posted: May 27, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcitriol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents