Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
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.
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.
Status: Active, not recruiting (N/A). Started on September 1st, 2005. Ended on April 1st, 2006.
Enrollment: 200 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Open Label
- Dose Comparison
- Crossover Assignment
- Efficacy Study
Conditions:
Interventions:
- Behavioral: Low Salt Diet versus High salt diet
Eligibility
Inclusion Criteria:
Subjects aged 40 years and above
With systolic BP <140 and diastolic < 90 mmHg
Not receiving pharmacological antihypertensive medications
Exclusion Criteria:
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
- Gender
Both
- Mininum Age
40 Years
- Maximum Age
N/A
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: Aga Khan University
Authority: Pakistan: Pakistan Medica Research Council
Locations
-
Aga Khan University
Karachi
Sindh
74800
Pakistan
Officials
Tazeen H Jafar, MD, MPH (Study Director, Aga Khan University)
Saleem Jessani, MBBS (Principal Investigator, Aga Khan University)
Sponsors
Aga Khan University (Lead Sponsor)
Wellcome Trust (Collaborator)
References
None.
Links
None.
- Date Verified
- April 1st, 2006
- First Received
- May 25th, 2006
- Last Changed
- May 25th, 2006
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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