Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330356
Status:
UNKNOWN
Last Update Posted:
2006-05-26
First Post:
2006-05-25
Brief Title:
Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 pressureHowever 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
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 pressureHowever 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 selectedInformed consent will be obtained
Each participant would then be randomized to either low salt sodium 20mmolday or high salt diet sodium 220mmolday 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
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 selectedInformed consent will be obtained
Each participant would then be randomized to either low salt sodium 20mmolday or high salt diet sodium 220mmolday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None