Overview

This trial is active, not recruiting.

Condition hypertension
Treatment low salt diet versus high salt diet
Sponsor Aga Khan University
Collaborator Wellcome Trust
Start date September 2005
End date April 2006
Trial size 200 participants
Trial identifier NCT00330356, 074825/Z/04/Z

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
time frame:

Secondary Outcomes

Measure
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.
time frame:
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.
time frame:

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
Principal investigator Saleem Jessani, MBBS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2006.
Information provided to ClinicalTrials.gov by Aga Khan University.