NCT05425030Completed
A Community Health Worker-Led LSSS Intervention in Bangladesh
Effectiveness of a Community Health Worker-Led Low-Sodium Salt Intervention to Reduce Blood Pressure: A Cluster Randomized Controlled Trial in Rural Bangladesh
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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 public health programs have attempted to find ways for people to reduce their salt intake to avoid these complications. These programs, however, have proven challenging, as asking people to alter their food preparation practices is often met with resistance. As such, we wish to test the blood pressure-lowering effects of low sodium salt substitute (LSSS), a salt substance in which a third of the compound by weight is composed of potassium (which does not increase blood pressure) rather than sodium. Additionally, the best way of supplying LSSS to people is yet unknown. We thus propose to study the effectiveness of an LSSS product by directly providing it via community health workers in 309 households in rural Bangladesh.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 618 (actual)
- First submitted
- 14 Jun 2022
- Start date
- 26 Jan 2023
- Primary completion date
- 30 May 2024
- Lead sponsor
- Stanford University
- Diseases
- High blood pressure
- NCT number
- NCT05425030
What you commit to
- Study type: Interventional
- Participants enrolled: 618
- From 26 Jan 2023 to the primary completion date, 30 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BRAC University, James P Grant School of Public Health Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.