An interventional study of Low Salt Diet versus High salt diet in Hypertension, sponsored by Aga Khan University. Status unknown at 1 site in Pakistan. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-05-26.
Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention
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.
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:
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 200 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects aged 40 years and above
Exclusion Criteria:
Subjects with following conditions would be excluded:
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
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.
This study is status unknown, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aga Khan University