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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: July 5, 2012
Last verified: July 2012
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • The blood pressure response to angiotensin II [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The renal blood flow response to angiotensin II [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013