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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

Tracking Information
First Submitted Date  ICMJE October 7, 2013
First Posted Date  ICMJE October 11, 2013
Last Update Posted Date August 25, 2017
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • Systolic blood pressure (mmHg) [ Time Frame: Three years ]
    We will assess changes in systolic 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 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.
  • Diastolic blood pressure (mmHg) [ Time Frame: Three years ]
    We will assess changes in 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). 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2013)
Cost-effectiveness analysis [ Time Frame: Three years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru
Official Title  ICMJE Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Blood Pressure
  • Hypertension
Intervention  ICMJE Other: Salt substitute
A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.
Study Arms  ICMJE 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.

Intervention: Other: Salt substitute
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2017)
2376
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2013)
2000
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960972
Other Study ID Numbers  ICMJE 5U01HL114180( U.S. NIH Grant/Contract )
58563 ( Other Identifier: UPCH SIDISI )
00004928 ( Other Identifier: JHU IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Data can be shared potentially when main papers are published.
Responsible Party Jaime Miranda, Universidad Peruana Cayetano Heredia
Study Sponsor  ICMJE Universidad Peruana Cayetano Heredia
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
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
PRS Account Universidad Peruana Cayetano Heredia
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP