HealthyEarly Phase 1NCT00590512
Dietary Salt Intake and Vascular Function
A Early Phase 1 study testing High sodium and Low sodium in people with Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High sodium and Low sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 2012
- Phase
- Early 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, African-American volunteers
- 18-35 years of age,
- No personal or first degree relative with hypertension or diabetes,
- Blood pressure <130/85 mmHg and > 90/60 at the screening visit,
- Body mass index <30 kg/m2,
- No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).
Who cannot join
- Alcohol intake >2 beverage/night,
- Smoking,
- Recreational drug use,
- Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
- Prescription or herbal medication use,
- Ischemic changes on resting electrocardiogram,
- Known hypersensitivity to any of the study drugs,
- Other active medical problems detected by examination or laboratory testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.
Read the detailed description
Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.
- Conditions
- Healthy
- Being tested
- High sodium, Low sodium
- Keywords
- dietary salt, sodium, blood vessels, vascular function, endothelial function, heart disease risk, cardiovascular disease risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High sodiumDietary supplement
Low sodiumDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| High Sodium | Active comparator | High sodium Receives: Dietary Supplement: High sodium |
| Low sodium | Active comparator | Low sodium Receives: Dietary Supplement: Low sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startMar 2005
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
- Investigators
- Rhonda Bentley-Lewis, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590512
- Sponsor's protocol ID
- 2004P002705
- Status last verified
- Aug 2013
- First submitted
- 28 Dec 2007
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Salt Intake and Vascular Function
- ClinicalTrials.gov ID
- NCT00590512
- Acronym / sponsor ID
- 2004P002705
- Conditions
- Healthy
- Keywords
- dietary salt, sodium, blood vessels, vascular function, endothelial function, heart disease risk, cardiovascular disease risk
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jan 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.
The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.
Detailed description
Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Sodium | Active comparator | Dietary Supplement: High sodiumHigh sodium |
| Low sodium | Active comparator | Dietary Supplement: Low sodiumLow sodium |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male, African-American volunteers
- 18-35 years of age,
- No personal or first degree relative with hypertension or diabetes,
- Blood pressure <130/85 mmHg and > 90/60 at the screening visit,
- Body mass index <30 kg/m2,
Key exclusion criteria (8 listed)
- Alcohol intake >2 beverage/night,
- Smoking,
- Recreational drug use,
- Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
- Prescription or herbal medication use,
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 |
|---|---|---|
| High sodium | Dietary supplement | High Sodium |
| Low sodium | Dietary supplement | Low sodium |
Primary outcome
endothelial function
Time frame: one week
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 29 Aug 2013.
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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.
Rhonda Bentley-Lewis, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing High sodium and Low sodium in people with Healthy, 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 6 inclusion and 8 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 29 Aug 2013. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
endothelial function (time frame: one week). 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 29 Aug 2013.