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Effects of Vitamin D on Renin Expression in Hypertensive Patients

Sponsor
University of Utah (Other)
Overall Status
Terminated
CT.gov ID
NCT00585442
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
13
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
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
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calcitriol

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

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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. [13 MONTHS (MAY 2007-JUNE 2008)]

    Secondary Outcome Measures

    1. Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [13 MONTHS (MAY 2007-JUNE 2008)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mark munger, Professor, Pharmacotherapy, University of Utah
    ClinicalTrials.gov Identifier:
    NCT00585442
    Other Study ID Numbers:
    • 22714
    • 10151812
    First Posted:
    Jan 3, 2008
    Last Update Posted:
    May 27, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Calcitriol

    Study Results

    No Results Posted as of May 27, 2016