This trial is active, not recruiting.

Conditions blood pressure, hypertension
Treatment salt substitute
Sponsor Universidad Peruana Cayetano Heredia
Collaborator Johns Hopkins University
Start date April 2014
End date March 2017
Trial size 2000 participants
Trial identifier NCT01960972, 00004928, 58563, 5U01HL114180


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
As described by Brown, in a stepped wedge design, an intervention is rolled-out sequentially to the trial participants (either as individuals or clusters of individuals) over a number of time periods. The order in which the different individuals or clusters receive the intervention is determined at random and, by the end of the random allocation, all individuals or groups will have received the intervention. Stepped wedge designs incorporate data collection at each point where a new group (step) receives the intervention. Thus, the salt substitute will be implemented in each cluster (village) in a randomized fashion. Not arms are needed since the 6 randomly-selected villages will be implemented in some moment of the protocol.
salt substitute
A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.

Primary Outcomes

Systolic/diastolic blood pressure (mmHg)
time frame: Three years

Secondary Outcomes

Progression to hypertension
time frame: Three years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru
Principal investigator Jaime Miranda, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universidad Peruana Cayetano Heredia.