Status:
RECRUITING
A Community Health Worker-Led LSSS Intervention in Bangladesh
Lead Sponsor:
Stanford University
Collaborating Sponsors:
BRAC University
Stanford King Center for Global Development
Conditions:
Blood Pressure
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The sodium found in salt is a powerful cause of high blood pressure, and most sodium ingested by humans is from their diet. High blood pressure is known to cause heart attacks and strokes, so various ...
Detailed Description
The overall objective of this study is to assess the effectiveness of providing access to low-sodium salt substitute (LSSS) (a compound in which a percentage of the sodium chloride (NaCl) is replaced ...
Eligibility Criteria
Inclusion
- Our target population is that of adults living in rural Bangladesh, while our study population will be comprised of adults (age ≥18 years old) living in Parbatipur, a rural/semi-rural sub-district in Dinajpur District (Rangpur Division), in the north of the country. Within Parbatipur, BRAC University has assessed 700 households for NCD risk factors as part of a larger Wellcome-trust funded multinational biobank (involving those living in Bangladesh, India, Pakistan, and Sri Lanka) to better understand the patterns and determinants of cardiovascular health in South Asian people in a cross-sectional analysis. All adults living in these surveyed households will be eligible to participate.
Exclusion
- Exclusion criteria include subjects taking potassium-sparing diuretics, already taking potassium supplements, or those who have known kidney disease at baseline.
- All adults initially screened for intervention will undergo serum creatinine testing, with those with values \>106 mMol/L for males and \>97 mMol/L for female excluded from the intervention but kept in the intervention group by intention-to-treat principles to avoid breaking of randomization.
- Although minors will not be involved in the study, to avoid spillover injury to children in the intervention households, all members of intervention households under the age of 18 will also undergo urine dipstick testing. If proteinuria is detected, the household will be excluded from receiving the LSSS intervention (but followed in the intervention arm to avoid breaking randomization).
Key Trial Info
Start Date :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05425030
Start Date
January 26 2023
End Date
December 30 2024
Last Update
March 21 2024
Active Locations (1)
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1
BRAC University, James P Grant School of Public Health
Dhaka, Mohakhali, Bangladesh, 68 Tajuddin Sarani