Blood PressureNCT01960972
Launching a Salt Substitute to Reduce Blood Pressure at the Population Level in Peru
A study testing Salt substitute in people with Blood Pressure and Hypertension, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Salt substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,376 participants
- Where
- 1 sitePeru
- Study dates
- Mar 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Self-reported history of chronic kidney disease or heart disease.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Peru1 site
Center for Global Health (Universidad Peruana Cayetano Heredia)
Tumbes
About this study
Official title: Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - 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.
Read the 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.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Salt substitute
- Keywords
- Blood pressure, Hypertension, Stepped wedge trial design
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt substituteOther
A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.
| Study group | Role | What they receive |
|---|---|---|
| Salt substitute | Experimental | 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. Receives: Other: Salt substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic/diastolic blood pressure (mmHg)
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.
Measured: Three years
Secondary outcomes (1)
Progression to hypertension
Using data of systolic and diastolic blood pressure, we will estimate progression towards hypertension among participants in intervened and control villages.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startMar 2014
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Jaime Miranda, Universidad Peruana Cayetano Heredia
- Investigators
- Jaime Miranda, MD, PhD, Principal investigator, Universidad Peruana Cayetano HerediaRobert H Gilman, MD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthAntonio Bernabe-Ortiz, MD, MPH, Study director, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960972
- Sponsor's protocol ID
- 5U01HL114180
- Other IDs
- 58563, 00004928
- Status last verified
- Aug 2021
- First submitted
- 7 Oct 2013
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data can be shared potentially when main papers are published.
Publications
Bernabe-Ortiz A, Diez-Canseco F, Gilman RH, Cardenas MK, Sacksteder KA, Miranda JJ. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru. Trials. 2014 Mar 25;15:93. doi: 10.1186/1745-6215-15-93.
PubMed 24667035Pesantes MA, Diez-Canseco F, Bernabe-Ortiz A, Ponce-Lucero V, Miranda JJ. Taste, Salt Consumption, and Local Explanations around Hypertension in a Rural Population in Northern Peru. Nutrients. 2017 Jul 5;9(7):698. doi: 10.3390/nu9070698.
PubMed 28678190Saavedra-Garcia L, Bernabe-Ortiz A, Gilman RH, Diez-Canseco F, Cardenas MK, Sacksteder KA, Miranda JJ. Applying the Triangle Taste Test to Assess Differences between Low Sodium Salts and Common Salt: Evidence from Peru. PLoS One. 2015 Jul 30;10(7):e0134700. doi: 10.1371/journal.pone.0134700. eCollection 2015.
PubMed 26225848Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cardenas MK, Carrillo-Larco RM, Diez-Canseco F, Pesantes MA, Sacksteder KA, Gilman RH, Miranda JJ. Effect of salt substitution on community-wide blood pressure and hypertension incidence. Nat Med. 2020 Mar;26(3):374-378. doi: 10.1038/s41591-020-0754-2. Epub 2020 Feb 17.
PubMed 32066973Lazo-Porras M, Del Valle A, Beran D, Pesantes MA, Perez-Leon S, Ponce-Lucero V, Bernabe-Ortiz A, Cardenas MK, Chappuis F, Perel P, Miranda JJ, Diez-Canseco F. Implementation of a salt substitute intervention using social marketing in resourced-limited communities in Peru: a process evaluation study. Front Public Health. 2023 May 19;11:1068624. doi: 10.3389/fpubh.2023.1068624. eCollection 2023.
PubMed 37275501
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Launching a Salt Substitute to Reduce Blood Pressure at the Population Level - Peru
- ClinicalTrials.gov ID
- NCT01960972
- Acronym / sponsor ID
- 5U01HL114180
- Conditions
- Blood Pressure, Hypertension
- Keywords
- Blood pressure, Hypertension, Stepped wedge trial design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,376 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salt substitute | Experimental | Other: Salt substituteAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Self-reported history of chronic kidney disease or heart disease.
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt substituteA salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages. | Other | Salt substitute |
Primary outcome
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.
1 secondary outcome
Progression to hypertension
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Background: PubMed 24667035Bernabe-Ortiz A, Diez-Canseco F, Gilman RH, Cardenas MK, Sacksteder KA, Miranda JJ. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru. Trials. 2014 Mar 25;15:93. doi: 10.1186/1745-6215-15-93.
- Results publication: PubMed 28678190Pesantes MA, Diez-Canseco F, Bernabe-Ortiz A, Ponce-Lucero V, Miranda JJ. Taste, Salt Consumption, and Local Explanations around Hypertension in a Rural Population in Northern Peru. Nutrients. 2017 Jul 5;9(7):698. doi: 10.3390/nu9070698.
- Results publication: PubMed 26225848Saavedra-Garcia L, Bernabe-Ortiz A, Gilman RH, Diez-Canseco F, Cardenas MK, Sacksteder KA, Miranda JJ. Applying the Triangle Taste Test to Assess Differences between Low Sodium Salts and Common Salt: Evidence from Peru. PLoS One. 2015 Jul 30;10(7):e0134700. doi: 10.1371/journal.pone.0134700. eCollection 2015.
- Results publication: PubMed 32066973Bernabe-Ortiz A, Sal Y Rosas VG, Ponce-Lucero V, Cardenas MK, Carrillo-Larco RM, Diez-Canseco F, Pesantes MA, Sacksteder KA, Gilman RH, Miranda JJ. Effect of salt substitution on community-wide blood pressure and hypertension incidence. Nat Med. 2020 Mar;26(3):374-378. doi: 10.1038/s41591-020-0754-2. Epub 2020 Feb 17.
- Derived from this study: PubMed 37275501Lazo-Porras M, Del Valle A, Beran D, Pesantes MA, Perez-Leon S, Ponce-Lucero V, Bernabe-Ortiz A, Cardenas MK, Chappuis F, Perel P, Miranda JJ, Diez-Canseco F. Implementation of a salt substitute intervention using social marketing in resourced-limited communities in Peru: a process evaluation study. Front Public Health. 2023 May 19;11:1068624. doi: 10.3389/fpubh.2023.1068624. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Data can be shared potentially when main papers are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Miranda, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
Robert H Gilman, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
Antonio Bernabe-Ortiz, MD, MPH study director
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt substitute in people with Blood Pressure and Hypertension, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic/diastolic blood pressure (mmHg) (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960972, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.