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Effects of Vitamin D on Renin Expression in Hypertensive Patients

Primary Purpose

Hypertension, Vitamin D Deficiency

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

calcitriol

Placebo

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcitriol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo.

Full Information

NCT ID

NCT00585442

First Posted

December 22, 2007

Last Updated

May 25, 2016

Sponsor

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT00585442

Brief Title

Effects of Vitamin D on Renin Expression in Hypertensive Patients

Official Title

Effects of Calcitriol (1α, 25-[OH]2 Vitamin D3) on Renin Expression in Hypertensive Patients Without Vitamin D Deficiency

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Terminated

Why Stopped

Lack of quality data

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calcitriol

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

calcitriol

Other Intervention Name(s)

Rocaltrol, 1α, 25-[OH]2 Vitamin D3

Intervention Description

1.0 mcg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Time Frame

13 MONTHS (MAY 2007-JUNE 2008)

Secondary Outcome Measure Information:

Title

Compare mononuclear leukocyte renin transcription (mRNA) between calcitriol and matched placebo.

Time Frame

13 MONTHS (MAY 2007-JUNE 2008)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Munger, PharmD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

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Effects of Vitamin D on Renin Expression in Hypertensive Patients

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