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Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01068418
First received: February 11, 2010
Last updated: March 1, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Obesity Vitamin D Deficiency Hypertension Dietary Supplement: Vitamin D (cholecalciferol)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

Resource links provided by NLM:


Further study details as provided by Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital:

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

Enrollment: 26
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068418

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
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
  More Information

Responsible Party: Jonathan S. Williams, MD, MMSc, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01068418     History of Changes
Other Study ID Numbers: 2009p002062
Study First Received: February 11, 2010
Results First Received: December 22, 2016
Last Updated: March 1, 2017

Keywords provided by Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital:
Obesity
Renin Angiotensin System
Vitamin D deficiency
Hypertension

Additional relevant MeSH terms:
Hypertension
Obesity
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 21, 2017