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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Vitamin D Deficiency | Drug: calcitriol Drug: Placebo | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 2007 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Calcitriol |
Drug: calcitriol
1.0 mcg daily
Other Names:
|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo |
- 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) ]
- Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo. [ Time Frame: 13 MONTHS (MAY 2007-JUNE 2008) ]

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585442
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | Mark Munger, PharmD | University of Utah |
Responsible Party: | mark munger, Professor, Pharmacotherapy, University of Utah |
ClinicalTrials.gov Identifier: | NCT00585442 |
Other Study ID Numbers: |
22714 10151812 ( Other Grant/Funding Number: American Foundation for Pharmaceutical Education ) |
First Posted: | January 3, 2008 Key Record Dates |
Last Update Posted: | May 27, 2016 |
Last Verified: | March 2016 |
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Calcitriol Vitamins Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents |