Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

NCT ID: NCT01068418

Last Updated: 2017-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Obesity Vitamin D Deficiency Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vitamin D3

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

Group Type EXPERIMENTAL

Vitamin D (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol 15,000 IU daily for 30 days

Interventions

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Vitamin D (cholecalciferol)

cholecalciferol 15,000 IU daily for 30 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonathan S. Williams, MD, MMSc

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan S Williams, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Anand Vaidya, MD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2009p002062

Identifier Type: -

Identifier Source: org_study_id

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