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Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

Primary Purpose

Obesity, Vitamin D Deficiency, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D (cholecalciferol)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity, Renin Angiotensin System, Vitamin D deficiency, Hypertension

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D3

Arm Description

15000IU of vitamin D3 daily: open-label, single-arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II

Full Information

First Posted
February 11, 2010
Last Updated
March 1, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01068418
Brief Title
Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity
Official Title
Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin D Deficiency, Hypertension
Keywords
Obesity, Renin Angiotensin System, Vitamin D deficiency, Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
15000IU of vitamin D3 daily: open-label, single-arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (cholecalciferol)
Intervention Description
cholecalciferol 15,000 IU daily for 30 days
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II
Time Frame
baseline and 1 month following vitamin D3 therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Williams, MD, MMSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anand Vaidya, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

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