HypertensionNCT00330356
Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
A study testing Low Salt Diet versus High salt diet in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
Trial summary
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Low Salt Diet versus High salt diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2005to Apr 2006
- Phase
- Interventional
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 40 years and above
- With systolic BP <140 and diastolic < 90 mmHg
- Not receiving pharmacological antihypertensive medications
Who cannot join
- Subjects with following conditions would be excluded:
- Diabetes mellitus (positive history of diabetes or fasting blood sugar ≥ 126 mg/dl)
- Renal insufficiency (serum creatinine of 1.4 mg/dl or above)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure relationship remains controversial.
While clinical practice guidelines recommend dietary salt restriction for lowering blood pressure, the relationship of salt with blood pressure has not been tested in the Pakistani population. Therefore, the efficacy of dietary salt restriction on blood pressure of this population remains to be determined. The study aims to determine the relationship between dietary salt intake and blood pressure in Pakistani population. It is hypothesized that alteration in the dietary salt intake demonstrates significant changes in the Systolic BP.
Read the detailed description
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure relationship remains controversial.
While clinical practice guidelines recommend dietary salt restriction for lowering blood pressure, the relationship of salt with blood pressure has not been tested in the Pakistani population. Therefore, the efficacy of dietary salt restriction on blood pressure of this population remains to be determined.
Objectives:
- To assess the effects of low salt diet versus high salt diet on blood pressure in normotensive adults aged 40 years or above in Karachi, Pakistan
- To estimate the prevalence of salt sensitivity and salt resistance in normotensive adults aged 40 years or above in Karachi, Pakistan
Study Design:
The proposed study is a prospective, randomized, crossover, open label evaluation trial.
Study Population \& setting:
For the proposed study, subjects age 40 or over without hypertension and fulfilling the eligibility criteria will be randomly selected.Informed consent will be obtained.
Each participant would then be randomized to either low salt (sodium 20mmol/day) or high salt diet (sodium 220mmol/day) for one week, with a washout period of regular diet for one week, and the reverse of initial randomization for another week.
Blood pressure at baseline and at the end of each intervention week would be measured using a calibrated automated device in the sitting position from the right arm after 5 minutes of rest using an appropriate sized cuff. Three consecutive readings with an interval of 05 minutes will be taken and the mean of the final two blood pressure readings will be used in the analysis. Compliance to the diet will be confirmed by measuring 24-hour urinary sodium and urinary creatinine throughout the study.
- Conditions
- Hypertension
- Being tested
- Low Salt Diet versus High salt diet
- Keywords
- Dietary Salt, Blood Pressure, Normotensives
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Salt Diet versus High salt dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
Secondary outcomes (2)
Salt Sensitivity defined as an increase in SBP of at least 8 mmHg at the end of high salt phase compared with the end of low salt phase.
Salt Resistance would be defined as those with rise of < 4 mm Hg of SBP at the end of high salt phase compared with the end of low salt phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startSep 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Investigators
- Tazeen H Jafar, MD, MPH, Study director, Aga Khan UniversitySaleem Jessani, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330356
- Sponsor's protocol ID
- 074825/Z/04/Z
- Status last verified
- Apr 2006
- First submitted
- 25 May 2006
- Last updated
- 26 May 2006
- Results posted
- No
Publications
Jessani S, Hatcher J, Chaturvedi N, Jafar TH. Effect of low vs. high dietary sodium on blood pressure levels in a normotensive Indo-Asian population. Am J Hypertens. 2008 Nov;21(11):1238-44. doi: 10.1038/ajh.2008.256. Epub 2008 Sep 4.
PubMed 18772855
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
- ClinicalTrials.gov ID
- NCT00330356
- Acronym / sponsor ID
- 074825/Z/04/Z
- Conditions
- Hypertension
- Keywords
- Dietary Salt, Blood Pressure, Normotensives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Sep 2005
- Study completion
- Apr 2006
- First posted
- 26 May 2006 (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.
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure relationship remains controversial.
While clinical practice guidelines recommend dietary salt restriction for lowering blood pressure, the relationship of salt with blood pressure has not been tested in the Pakistani population. Therefore, the efficacy of dietary salt restriction on blood pressure of this population remains to be determined. The study aims to determine the relationship between dietary salt intake and blood pressure in Pakistani population. It is hypothesized that alteration in the dietary salt intake demonstrates significant changes in the Systolic BP.
Detailed description
High blood pressure is a global public health problem in developed and developing countries including Pakistan. Various studies conducted around the world have linked salt intake to variation in the blood pressure.However, definite conclusions are lacking and the exact role of dietary salt in salt-blood pressure relationship remains controversial.
While clinical practice guidelines recommend dietary salt restriction for lowering blood pressure, the relationship of salt with blood pressure has not been tested in the Pakistani population. Therefore, the efficacy of dietary salt restriction on blood pressure of this population remains to be determined.
Objectives:
- To assess the effects of low salt diet versus high salt diet on blood pressure in normotensive adults aged 40 years or above in Karachi, Pakistan
- To estimate the prevalence of salt sensitivity and salt resistance in normotensive adults aged 40 years or above in Karachi, Pakistan
Study Design:
The proposed study is a prospective, randomized, crossover, open label evaluation trial.
Study Population \& setting:
For the proposed study, subjects age 40 or over without hypertension and fulfilling the eligibility criteria will be randomly selected.Informed consent will be obtained.
Each participant would then be randomized to either low salt (sodium 20mmol/day) or high salt diet (sodium 220mmol/day) for one week, with a washout period of regular diet for one week, and the reverse of initial randomization for another week.
Blood pressure at baseline and at the end of each intervention week would be measured using a calibrated automated device in the sitting position from the right arm after 5 minutes of rest using an appropriate sized cuff. Three consecutive readings with an interval of 05 minutes will be taken and the mean of the final two blood pressure readings will be used in the analysis. Compliance to the diet will be confirmed by measuring 24-hour urinary sodium and urinary creatinine throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 40 years and above
Key exclusion criteria (4 listed)
- Subjects with following conditions would be excluded:
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 |
|---|---|---|
| Low Salt Diet versus High salt diet | Behavioural | – |
Primary outcome
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
2 secondary outcomes
Salt Sensitivity defined as an increase in SBP of at least 8 mmHg at the end of high salt phase compared with the end of low salt phase.
Salt Resistance would be defined as those with rise of < 4 mm Hg of SBP at the end of high salt phase compared with the end of low salt phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2006.
- Derived from this study: PubMed 18772855Jessani S, Hatcher J, Chaturvedi N, Jafar TH. Effect of low vs. high dietary sodium on blood pressure levels in a normotensive Indo-Asian population. Am J Hypertens. 2008 Nov;21(11):1238-44. doi: 10.1038/ajh.2008.256. Epub 2008 Sep 4.
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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.
Tazeen H Jafar, MD, MPH study director
Aga Khan University
Saleem Jessani, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Salt Diet versus High salt diet in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 May 2006. 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 Pakistan. 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?
Results are not available in the source record.
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?
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330356, which also lists 1 linked publication.
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 26 May 2006.