Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity

Obesity Clinical Trial

Official title:

Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068418
• Other study ID #: 2009p002062
• Status: Completed
• Phase: N/A
• First received: February 11, 2010
• Last updated: July 5, 2012
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D (cholecalciferol)
cholecalciferol 15,000 IU daily for 30 days

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The blood pressure response to angiotensin II		1.5 years	No
Secondary	The renal blood flow response to angiotensin II		1.5 years	No