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Completed

NCT Number: NCT01960972

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

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.

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Key information

Conditions

Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Global Health (Universidad Peruana Cayetano Heredia)

Tumbes, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salt substitute

Other

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

Primary outcomes

  1. Systolic/diastolic blood pressure (mmHg)

    Time frame: Three years

    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.

Secondary outcomes

  1. Progression to hypertension

    Time frame: Three years

    Using data of systolic and diastolic blood pressure, we will estimate progression towards hypertension among participants in intervened and control villages.

Other outcomes

  1. Cost-effectiveness analysis

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Universidad Peruana Cayetano Heredia

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 11, 2013
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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