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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Aga Khan University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wellcome Trust
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00330356
First received: May 25, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Low Salt Diet versus High salt diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

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.

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330356

Locations
Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Wellcome Trust
Investigators
Study Director: Tazeen H Jafar, MD, MPH Aga Khan University
Principal Investigator: Saleem Jessani, MBBS Aga Khan University
  More Information

No publications provided by Aga Khan University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00330356     History of Changes
Other Study ID Numbers: 074825/Z/04/Z
Study First Received: May 25, 2006
Last Updated: May 25, 2006
Health Authority: Pakistan: Pakistan Medica Research Council

Keywords provided by Aga Khan University:
Dietary Salt
Blood Pressure
Normotensives

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014