InflammationPhase 1NCT00700479
Studies on Aldosterone and Vascular Function
A Phase 1 study testing aldosterone and low or high sodium diet in people with Inflammation, run by Yale University at 1 site in United States.
Trial summary
A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- aldosterone and low or high sodium diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects age >18 years
Who cannot join
- Any chronic medical disease or chronic use of medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.
- Conditions
- Inflammation
- Being tested
- aldosterone, low or high sodium diet, placebo
- Keywords
- vascular endothelium, nitric oxide, aldosterone, vascular biology
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldosteroneDrug
4 hour infusion
low or high sodium dietDietary supplement
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Aldosterone plus low salt diet Receives: Drug: aldosterone; Dietary Supplement: low or high sodium diet |
| B | Experimental | Aldosterone plus high sodium diet Receives: Drug: aldosterone; Dietary Supplement: low or high sodium diet |
| C | Placebo comparator | Placebo plus low sodium diet Receives: Dietary Supplement: low or high sodium diet; Drug: placebo |
| D | Placebo comparator | placebo plus high sodium diet Receives: Dietary Supplement: low or high sodium diet; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation brachial artery
Measured: 0 and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Stuart Katz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700479
- Sponsor's protocol ID
- 602001143
- Status last verified
- Jun 2008
- First submitted
- 25 Dec 2007
- Last updated
- 18 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Aldosterone and Vascular Function
- ClinicalTrials.gov ID
- NCT00700479
- Acronym / sponsor ID
- 602001143
- Conditions
- Inflammation
- Keywords
- vascular endothelium, nitric oxide, aldosterone, vascular biology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized crossover trial to determine the effects of sodium loading and aldosterone infusion on endothelial function in normal subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: aldosterone, Dietary Supplement: low or high sodium dietAldosterone plus low salt diet |
| B | Experimental | Drug: aldosterone, Dietary Supplement: low or high sodium dietAldosterone plus high sodium diet |
| C | Placebo comparator | Dietary Supplement: low or high sodium diet, Drug: placeboPlacebo plus low sodium diet |
| D | Placebo comparator | Dietary Supplement: low or high sodium diet, Drug: placeboplacebo plus high sodium diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy subjects age >18 years
Key exclusion criteria (1 listed)
- Any chronic medical disease or chronic use of medications
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 |
|---|---|---|
| aldosterone4 hour infusion | Drug | A, B |
| low or high sodium diet | Dietary supplement | A, B, C, D |
| placeboplacebo | Drug | C, D |
Primary outcome
Flow mediated dilation brachial artery
Time frame: 0 and 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2008.
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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.
Stuart Katz, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aldosterone and low or high sodium diet in people with Inflammation, run by Yale University 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 1 inclusion and 1 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 18 Jun 2008. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flow mediated dilation brachial artery (time frame: 0 and 4 hours). 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 18 Jun 2008.