Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru
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|ClinicalTrials.gov Identifier: NCT01960972|
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : August 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Hypertension||Other: Salt substitute||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2376 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Salt substitute
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.
Other: Salt substitute
A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.
- 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.
- 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.
- Cost-effectiveness analysis [ Time Frame: Three years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960972
|Center for Global Health (Universidad Peruana Cayetano Heredia)|
|Principal Investigator:||Jaime Miranda, MD, PhD||Universidad Peruana Cayetano Heredia|
|Principal Investigator:||Robert H Gilman, MD||Johns Hopkins Bloomberg School of Public Health|
|Study Director:||Antonio Bernabe-Ortiz, MD, MPH||Universidad Peruana Cayetano Heredia|