ObesityNCT01068418
Vitamin D Supplementation Reduces Renin-Angiotensin System Activity in Obesity
A study testing Vitamin D (cholecalciferol) in people with Obesity and Vitamin D Deficiency, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Vitamin D Deficiency, Hypertension
- What is being tested?
- Vitamin D (cholecalciferol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age < 65,
- Cr < 1.6,
- 25-hydroxyvitamin D < 25 ng/mL,
- BMI > 30 kg/m2,
- stage I hypertension.
Who cannot join
- diabetes,
- coronary heart disease,
- heart failure,
- renal failure,
- liver failure,
- hyperparathyroidism,
- granulomatous disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Vitamin D Deficiency Augments 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.
Read the 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.
- Conditions
- Obesity, Vitamin D Deficiency, Hypertension
- Being tested
- Vitamin D (cholecalciferol)
- Keywords
- Obesity, Renin Angiotensin System, Vitamin D deficiency, Hypertension
- Medical subject headings
- Obesity, Vitamin D Deficiency, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (cholecalciferol)Dietary supplement
cholecalciferol 15,000 IU daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | 15000IU of vitamin D3 daily: open-label, single-arm Receives: Dietary Supplement: Vitamin D (cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in the Mean Arterial Blood Pressure in Response to an Infusion of Angiotensin II
Measured: 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
Measured: baseline and 1 month following vitamin D3 therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan S. Williams, MD, MMSc, Brigham and Women's Hospital
- Investigators
- Jonathan S Williams, MD, MMSc, Principal investigator, Brigham and Women's HospitalAnand Vaidya, MD, Study director, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068418
- Sponsor's protocol ID
- 2009p002062
- Status last verified
- Mar 2017
- First submitted
- 11 Feb 2010
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency Augments Renin-Angiotensin System Activity in Obesity
- ClinicalTrials.gov ID
- NCT01068418
- Acronym / sponsor ID
- 2009p002062
- Conditions
- Obesity, Vitamin D Deficiency, Hypertension
- Keywords
- Obesity, Renin Angiotensin System, Vitamin D deficiency, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Posted 14 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D (cholecalciferol)15000IU of vitamin D3 daily: open-label, single-arm |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age < 65,
- Cr < 1.6,
- 25-hydroxyvitamin D < 25 ng/mL,
- BMI > 30 kg/m2,
- stage I hypertension.
Key exclusion criteria (7 listed)
- diabetes,
- coronary heart disease,
- heart failure,
- renal failure,
- liver failure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D (cholecalciferol)cholecalciferol 15,000 IU daily for 30 days | Dietary supplement | Vitamin D3 |
Primary outcome
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
1 secondary outcome
The Change in Renal Blood Flow in Response to an Infusion of Angiotensin II
Time frame: baseline and 1 month following vitamin D3 therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan S Williams, MD, MMSc principal investigator
Brigham and Women's Hospital
Anand Vaidya, MD study director
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (cholecalciferol) in people with Obesity and Vitamin D Deficiency, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.