Effects of Vitamin D on Renin Expression in Hypertensive Patients

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. Identifier: NCT00585442
Recruitment Status : Terminated (Lack of quality data)
First Posted : January 3, 2008
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
mark munger, University of Utah

December 22, 2007
January 3, 2008
May 27, 2016
May 2007
June 2008   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT00585442 on Archive Site
Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ]
Same as current
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Effects of Vitamin D on Renin Expression in Hypertensive Patients
Effects of Calcitriol (1α, 25-[OH]2 Vitamin D3) on Renin Expression in Hypertensive Patients Without Vitamin D Deficiency
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.
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Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Vitamin D Deficiency
  • Drug: calcitriol
    1.0 mcg daily
    Other Names:
    • Rocaltrol
    • 1α, 25-[OH]2 Vitamin D3
  • Drug: Placebo
  • Experimental: Calcitriol
    Intervention: Drug: calcitriol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2008
June 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
10151812 ( Other Grant/Funding Number: American Foundation for Pharmaceutical Education )
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mark munger, University of Utah
University of Utah
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Principal Investigator: Mark Munger, PharmD University of Utah
University of Utah
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP