Effects of Low Salt Diet Versus High Salt Diet on Blood Pressure
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Sep 2005
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 25, 2006
CompletedFirst Posted
Study publicly available on registry
May 26, 2006
CompletedMay 26, 2006
April 1, 2006
May 25, 2006
May 25, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in mean systolic blood pressure (SBP) between completion of the high salt phase compared with the low salt phase.
Secondary Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects aged 40 years and above
- With systolic BP \<140 and diastolic \< 90 mmHg
- Not receiving pharmacological antihypertensive medications
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aga Khan Universitylead
- Wellcome Trustcollaborator
Study Sites (1)
Aga Khan University
Karachi, Sindh, 74800, Pakistan
Related Publications (1)
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.
PMID: 18772855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tazeen H Jafar, MD, MPH
Aga Khan University
- PRINCIPAL INVESTIGATOR
Saleem Jessani, MBBS
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2006
First Posted
May 26, 2006
Study Start
September 1, 2005
Study Completion
April 1, 2006
Last Updated
May 26, 2006
Record last verified: 2006-04