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Completed

NCT Number: NCT01068418

Vitamin D Supplementation Reduces 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.

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Key information

Conditions

Obesity Avitaminosis Body Weight Cardiovascular Diseases Deficiency Diseases Hypertension Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vitamin D Deficiency

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D (cholecalciferol)

Dietary Supplement

cholecalciferol 15,000 IU daily for 30 days

Primary outcomes

  1. 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 outcomes

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

    Time frame: baseline and 1 month following vitamin D3 therapy

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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