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Trial record 27 of 1405 for:    Peru

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
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Jaime Miranda, Universidad Peruana Cayetano Heredia

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.


Condition or disease Intervention/treatment Phase
Blood Pressure Hypertension Other: Salt substitute Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2376 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium Sodium

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Cost-effectiveness analysis [ Time Frame: Three years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Peru
Center for Global Health (Universidad Peruana Cayetano Heredia)
Tumbes, Peru
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Johns Hopkins University
Investigators
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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

Additional Information:
Publications of Results:
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Responsible Party: Jaime Miranda, Research Professor, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01960972     History of Changes
Other Study ID Numbers: 5U01HL114180 ( U.S. NIH Grant/Contract )
58563 ( Other Identifier: UPCH SIDISI )
00004928 ( Other Identifier: JHU IRB )
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data can be shared potentially when main papers are published.
Keywords provided by Jaime Miranda, Universidad Peruana Cayetano Heredia:
Blood pressure
Hypertension
Stepped wedge trial design
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases