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Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low Salt Diet versus High salt diet
Sponsored by
Aga Khan University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Dietary Salt, Blood Pressure, Normotensives

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 25, 2006
Last Updated
May 25, 2006
Sponsor
Aga Khan University
Collaborators
Wellcome Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00330356
Brief Title
Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
Official Title
Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aga Khan University
Collaborators
Wellcome Trust

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Dietary Salt, Blood Pressure, Normotensives

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Low Salt Diet versus High salt diet
Primary Outcome Measure Information:
Title
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tazeen H Jafar, MD, MPH
Organizational Affiliation
Aga Khan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Saleem Jessani, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18772855
Citation
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.
Results Reference
derived

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Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure

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