Trials / Completed
CompletedNCT01960972
Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru
Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,376 (actual)
- Sponsor
- Universidad Peruana Cayetano Heredia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This protocol aims to implement, using a stepped wedge trial design, a population-level intervention to replace high-sodium salt for a salt substitute (low-sodium, high-potassium salt) to reduce blood pressure levels among adults aged 18 years and over of the semi-urban area of Tumbes. We hypothesize that participants aged 18 years and over from villages receiving a salt substitute will have lower blood pressure compared to control villages.
Detailed description
Several randomized clinical trials and meta-analysis have reported that reduction of sodium intake decreases blood pressure. Also, the increase of potassium ingestion in minimal doses has been found in systematic reviews to produce a small reduction in blood pressure levels. The proposed intervention is a community-wide mass-strategy in which direct delivery of a salt substitute to households is accompanied by wide social marketing campaigns, both before and during the intervention period. With this experimental stepped wedge trial design, we will estimate the impact of a reduced-sodium salt substitution program on blood pressure at the population level. We propose the following specific aims: Specific Aim 1: To implement and assess the impact of an intervention using a salt substitute on blood pressure at the population level using a stepped wedge trial design. Specific Aim 2: To determine costs and efficacy of this implementation strategy using cost-effectiveness analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Salt substitute | A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2017-03-01
- Completion
- 2017-04-01
- First posted
- 2013-10-11
- Last updated
- 2021-08-26
Locations
1 site across 1 country: Peru
Source: ClinicalTrials.gov record NCT01960972. Inclusion in this directory is not an endorsement.