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Effects of Vitamin D on Renin Expression in Hypertensive Patients

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

Tracking Information
First Submitted Date  ICMJE December 22, 2007
First Posted Date  ICMJE January 3, 2008
Last Update Posted Date May 27, 2016
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2008)
Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Vitamin D on Renin Expression in Hypertensive Patients
Official Title  ICMJE Effects of Calcitriol (1α, 25-[OH]2 Vitamin D3) on Renin Expression in Hypertensive Patients Without Vitamin D Deficiency
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Vitamin D Deficiency
Intervention  ICMJE
  • Drug: calcitriol
    1.0 mcg daily
    Other Names:
    • Rocaltrol
    • 1α, 25-[OH]2 Vitamin D3
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Calcitriol
    Intervention: Drug: calcitriol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
12
Original Actual Enrollment  ICMJE
 (submitted: January 2, 2008)
6
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00585442
Other Study ID Numbers  ICMJE 22714
10151812 ( Other Grant/Funding Number: American Foundation for Pharmaceutical Education )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party mark munger, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Munger, PharmD University of Utah
PRS Account University of Utah
Verification Date March 2016

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