Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

March 1, 2017 updated by: Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital

Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3
15000IU of vitamin D3 daily: open-label, single-arm
Dietary supplement: Vitamin D (cholecalciferol)
cholecalciferol 15,000 IU daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline and 1 month following vitamin D3 therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II
Time Frame: baseline and 1 month following vitamin D3 therapy
baseline and 1 month following vitamin D3 therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Jonathan S Williams, MD, MMSc, Brigham and Women's Hospital
  • Study Director: Anand Vaidya, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009p002062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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