Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru

Hypertension Clinical Trial

Official title:

Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960972
• Other study ID #: 5U01HL114180
• Secondary ID: 5856300004928
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2021
• Source: Universidad Peruana Cayetano Heredia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2376
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Other:
• Salt substitute
A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.

Locations

Country	Name	City	State
Peru	Center for Global Health (Universidad Peruana Cayetano Heredia)	Tumbes

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia	Johns Hopkins University

Country where clinical trial is conducted

Peru, 

References & Publications (4)

Bernabe-Ortiz A, Diez-Canseco F, Gilman RH, Cárdenas 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. — View Citation

Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cárdenas 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; — View Citation

Pesantes MA, Diez-Canseco F, Bernabé-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). pii: E698. doi: 10.3390/nu9070698. — View Citation

Saavedra-Garcia L, Bernabe-Ortiz A, Gilman RH, Diez-Canseco F, Cárdenas 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):e013470 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness analysis		Three years
Primary	Systolic/diastolic blood pressure (mmHg)	We will assess changes in systolic and diastolic blood pressure over time. Periodic assessments will be carried out to obtain clinical measurements. Every five months, a new evaluation will be performed in all participant villages (intervention and control).; Systolic and diastolic blood pressure will be measured in triplicate using standard procedures and automated and validated devices. These periodic assessments will be taken at each household to guarantee contact with each family member enrolled in this study.	Three years
Secondary	Progression to hypertension	Using data of systolic and diastolic blood pressure, we will estimate progression towards hypertension among participants in intervened and control villages.	Three years

External Links

•   Global Alliance for Chronic Diseases