Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity
Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity
1 other identifier
interventional
26
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
February 14, 2017
CompletedMarch 30, 2017
March 1, 2017
1.6 years
February 11, 2010
December 22, 2016
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II
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
baseline and 1 month following vitamin D3 therapy
Study Arms (1)
Vitamin D3
EXPERIMENTAL15000IU of vitamin D3 daily: open-label, single-arm
Interventions
Eligibility Criteria
You may qualify if:
- age \< 65,
- Cr \< 1.6,
- hydroxyvitamin D \< 25 ng/mL,
- BMI \> 30 kg/m2,
- stage I hypertension.
You may not qualify if:
- diabetes,
- coronary heart disease,
- heart failure,
- renal failure,
- liver failure,
- hyperparathyroidism,
- granulomatous disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This was a small physiologic study intended to provide insights on the influence of vitamin D3 on the renin-angiotensin system and vascular function. It is not generalizable to clinical practice. This is not a standard "clinical trial".
Results Point of Contact
- Title
- Jonathan S. Williams
- Organization
- Brigham and Women's Hospital, Harvard Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan S Williams, MD, MMSc
Brigham and Women's Hospital
- STUDY DIRECTOR
Anand Vaidya, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 15, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
March 30, 2017
Results First Posted
February 14, 2017
Record last verified: 2017-03