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Clinical Trials/NCT01068418
NCT01068418CompletedNot Applicable

Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

Brigham and Women's Hospital2 sites in 1 country26 target enrollmentStarted: February 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II

Study Overview

Brief Summary

Hypothesis: Vitamin D supplementation lower renin-angiotensin system activity in obesity.

Specific Aim: To investigate whether Vitamin D supplementation in obesity improves the vascular sensitivity to angiotensin II.

Detailed Description

Vitamin D deficiency and obesity are international epidemics that have both been associated with increased activity of the renin-angiotensin system (RAS). Because increased RAS activity is associated with cardiovascular disease, interventions to lower RAS will have favorable public health impacts.

This study aims to evaluate whether the supplementation of Vitamin D in obese subjects will lower local tissue RAS activity. RAS activity will be evaluated by cross-sectional measurement of RAS components and by quantifying the vascular response to an infusion of angiotensin II. Subjects will be studied while Vitamin D deficient, and will return for repeat study following Vitamin D supplementation, for comparison.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age < 65,
  • Cr < 1.6,
  • 25-hydroxyvitamin D < 25 ng/mL,
  • BMI > 30 kg/m2,
  • stage I hypertension.

Exclusion Criteria

  • diabetes,
  • coronary heart disease,
  • heart failure,
  • renal failure,
  • liver failure,
  • hyperparathyroidism,
  • granulomatous disease.

Outcomes

Primary Outcomes

The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II

Time Frame: baseline and 1 month following vitamin D3 therapy

Secondary Outcomes

  • The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II(baseline and 1 month following vitamin D3 therapy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jonathan S. Williams, MD, MMSc

Assistant Professor of Medicine

Brigham and Women's Hospital

Study Sites (2)

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