Effects of Vitamin D on Renin Expression in Hypertensive Patients
Stopped early · Early Phase 1 · Has a placebo group
Conditions studied: Hypertension, Vitamin D Deficiency
In brief
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.
Key facts
- Study ID
- NCT00585442
- Run by
- University of Utah
- People needed
- 12
- Starts
- 2007-05-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2016-05-27
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients age > 55 years.
- Female patients must be postmenopausal, as determined by surgical hysterectomy or 12 month history since last active menstruation
- Stage I hypertension (JNC VII Criteria): mean systolic blood pressure (mSBP) 140-159 mmHg and mean diastolic blood pressure 90 - 99 mmHg (mDBP)2
- Provide informed consent
You may not qualify if…
- Serum vitamin D <55 pmol/L
- Serum calcium >10.5 mg/dL
- Serum phosphate (inorganic) >5.5 mg/dL
- Serum parathyroid hormone (PTH) >1.3 pmol/L
- Vitamin D supplements, calcium supplements, estrogen replacement therapy, corticosteroids (inhaled/oral), or hydroxymethyl glutarate CoA reductase inhibitors (statins) within 30 days prior to randomization
- Stage II hypertension (JNC VII criteria): mSSBP >160 mmHg or mSDBP >100 mmHg
- Use of alpha2-agonists, beta-blockers, or more than 2 anti-hypertensive medications at screening
- Estimated creatinine clearance <30 mL/min by Crockroft-Gault Formula
- 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
- Insulin dependent diabetes mellitus (patients stabilized on oral regimens may be enrolled)
- History of hypersensitivity reaction to 1α, 25-(OH)2 vitamin D3 (calcitriol)
Where it is running
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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