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

December 22, 2007
July 28, 2011
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585442 on ClinicalTrials.gov Archive Site
Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Vitamin D Deficiency
Drug: calcitriol
1.0 mcg daily
Other Names:
  • Rocaltrol
  • 1α, 25-[OH]2 Vitamin D3
Experimental: A
Intervention: Drug: calcitriol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
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)
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585442
22714, 10151812
Yes
University of Utah, Univerisity of Utah
University of Utah
Not Provided
Principal Investigator: Mark Munger, PharmD University of Utah
University of Utah
July 2011

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