Clinical trial NCT01960972: Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru
Official title: Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Keywords: Blood pressure
Hypertension
Stepped wedge trial design
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2013-10-11
Enrollment: 2376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years and over from the randomly selected villages.
* Capable of understanding study procedures and providing informed consent.
* Full-time resident in the area.

Exclusion Criteria:

* Self-reported history of chronic kidney disease or heart disease.
* Refusal to participate.

Primary outcomes:
measure: Systolic/diastolic blood pressure (mmHg)
timeFrame: Three years
Secondary outcomes:
measure: Progression to hypertension
timeFrame: Three years
Other outcomes:
measure: Cost-effectiveness analysis
timeFrame: Three years
Locations:
city: Tumbes
country: Peru
facility: Center for Global Health (Universidad Peruana Cayetano Heredia)
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Jaime Miranda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Robert H Gilman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Peruana Cayetano Heredia
name: Antonio Bernabe-Ortiz, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Bernabe-Ortiz A, Diez-Canseco F, Gilman RH, Cardenas MK, Sacksteder KA, Miranda JJ. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru. Trials. 2014 Mar 25;15:93. doi: 10.1186/1745-6215-15-93.
citation: Pesantes MA, Diez-Canseco F, Bernabe-Ortiz A, Ponce-Lucero V, Miranda JJ. Taste, Salt Consumption, and Local Explanations around Hypertension in a Rural Population in Northern Peru. Nutrients. 2017 Jul 5;9(7):698. doi: 10.3390/nu9070698.
citation: Saavedra-Garcia L, Bernabe-Ortiz A, Gilman RH, Diez-Canseco F, Cardenas MK, Sacksteder KA, Miranda JJ. Applying the Triangle Taste Test to Assess Differences between Low Sodium Salts and Common Salt: Evidence from Peru. PLoS One. 2015 Jul 30;10(7):e0134700. doi: 10.1371/journal.pone.0134700. eCollection 2015.
citation: Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cardenas MK, Carrillo-Larco RM, Diez-Canseco F, Pesantes MA, Sacksteder KA, Gilman RH, Miranda JJ. Effect of salt substitution on community-wide blood pressure and hypertension incidence. Nat Med. 2020 Mar;26(3):374-378. doi: 10.1038/s41591-020-0754-2. Epub 2020 Feb 17.