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Blood PressureRAISEDNCT05912426

Preventing the Rise in Blood Pressure With Age Using Reduced-sodium Salt

A study testing Reduced-sodium potassium-enriched salt in people with Blood Pressure, run by The George Institute at 2 sites in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a small-scale, short-term unblinded feasibility study to explore the acceptability and feasibility of implementing a reduced-sodium iodised salt intervention in Nigeria. Read more about this study

Who is it for?
Ages 6 years and olderHealthy volunteers can take part
Conditions the study is for
Blood Pressure
What is being tested?
Reduced-sodium potassium-enriched salt
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
2 sitesNigeria
Study dates
5 Mar 2024to 20 May 2024
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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • At least one household member is a child or adolescent (6-17 years) and at least one household member is an adult (≥18 years)
  • All household members consume greater than half of meals as food prepared in the home (self-report)
  • All household members provide signed informed consent/assent (consent obtained from legal guardians for those <18 years of age; assent also obtained from children/adolescents ≥12 years of age)

Who cannot join

  • Any household member has serious renal impairment.
  • Any household member uses a potassium-sparing diuretic.
  • Any household member uses a potassium supplement.
  • Any household member has other reason for concern about the use of reduced-sodium salt.

Trial locations and contacts

2 sites in 1 country.

Nigeria2 sites

  • Gofidna

    Abuja Municipal Area Council, Federal Capital Territory

  • Jahi-2

    Abuja Municipal Area Council, Federal Capital Territory

Other trials in Nigeria

About this study

Official title: A Non-randomised Feasibility Study for a Large-scale Clinical Trial (Phase II) Testing Reduced-sodium Salt for the Prevention of the Rise in Blood Pressure With Age Among Children and Adults (6+ Years) in Nigeria (RAISED)

The study is a small-scale, short-term unblinded feasibility study to explore the acceptability and feasibility of implementing a reduced-sodium iodised salt intervention in Nigeria. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age.

Read the detailed description

Reduced-sodium salts are a proven method for reducing sodium intake and lowering blood pressure. No studies to date have tested the effects of sodium reduction on the rise in blood pressure with age during adulthood or the critical periods of childhood and adolescence. The investigators want to explore whether reducing dietary sodium intake using reduced-sodium salt in comparison to regular salt, will attenuate the rise in blood pressure with age. This feasibility study aims to determine the feasibility of implementing a reduced-sodium iodised salt (66% potassium chloride, 34% sodium chloride) intervention in Nigeria. Specifically, the investigators will explore the feasibility of recruiting households with at least one child or adolescent 6-17 years of age and one adult ≥18 years, the acceptability of the reduced-sodium salt intervention, adherence to study procedures and data collection methods, and the effect of the reduced-sodium salt intervention on blood pressure. Secondary outcomes include household eligibility, household composition, willingness to engage in monthly follow-up visits in a longer-term trial, blood pressure, urinary sodium and potassium concentrations, height and weight. This study will be used to inform a large-scale intervention trial comparing the effects of reduced-sodium salt versus regular salt on the rise in blood pressure with age. The study will be conducted in two rural communities in Nigeria and will recruit 30 households (approximately 150 participants). All participants will be provided with the reduced-sodium salt intervention to replace all regular salt used for cooking, seasoning and food preservation over a 2-month period; there will be no control. Follow-up visits will be at 1 month and 2 months after the baseline visit, conducted either at the home or a local community healthcare centre.

Conditions
Blood Pressure
Being tested
Reduced-sodium potassium-enriched salt
Keywords
Reduced-sodium salt, Potassium-enriched salt, Salt reduction, Blood pressure, Salt, Feasibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reduced-sodium potassium-enriched saltBehavioural

    Supply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride).

Study groups in NCT05912426
Study groupRoleWhat they receive
Reduced-sodium potassium-enriched saltExperimentalReduced-sodium potassium-enriched salt
Receives: Behavioral: Reduced-sodium potassium-enriched salt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of recruitment

    Measured as the number of households recruited each month

    Measured: 2 months

  2. Adherence to the reduced-sodium salt intervention

    Measured as the self-reported proportion of regular salt replaced with intervention salt at each follow-up visit. The investigators will also estimate the quantity of intervention salt used by the household at each follow-up visit by visually estimating the amount of intervention salt that remains unused.

    Measured: 2 months

  3. Acceptability of the reduced-sodium salt intervention

    Measured as the percentage of participants that identify 'good', 'really good' or 'super good' on a brief questionnaire administered at the 2-month follow-up visit

    Measured: 2 months

  4. Completion rate of visits

    Measured as the percentage of participants that provide key data points (e.g., blood pressure, safety) at each visit

    Measured: 2 months

Secondary outcomes (7)

  1. Total number and percentage of households eligible to participate in the study

    Measured as the number of eligible households over the number of households approached at registration visits.

    Measured: 2 months

  2. Average number of participants per household and breakdown by age group

    Measured: 2 months

  3. Willingness to engage in monthly follow-up visits in a longer-term trial (48-months)

    Measured as the percentage of participants that identify as 'willing', 'very willing' or 'super willing' on a brief questionnaire administered at the 2-month follow-up visit

    Measured: 2 months

  4. Systolic and diastolic blood pressure

    Measured using validated and automated sphygmomanometers, according to standard practices and definitions outlined in the Global Alliance for Chronic Disease (GACD) data dictionary

    Measured: 2 months

  5. Urinary sodium concentration

    Measured as the mmol/L of sodium from a spot urine sample

    Measured: 2 months

  6. Urinary potassium concentration

    Measured as the mmol/L of potassium from a spot urine sample

    Measured: 2 months

  7. Weight

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start5 Mar 2024
  3. Primary completion20 May 2024
  4. Study completion20 May 2024

Resources

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
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912426
Sponsor's protocol ID
HC230273
Other IDs
UATH/HREC/PR/2023/06/084
Acronym
RAISED
Status last verified
Aug 2024
First submitted
31 May 2023
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data may be used for future research purposes or shared with other researchers. Researchers wishing to obtain data for secondary research purposes must place a request with the Principal Investigator (Prof Bruce Neal) and provide a copy of their ethics approval. If the request is approved, the Principal Investigator will provide remote access to the data to other researchers via a remote data access service. All data will be made available in a de-identified format with unique participant and household Identifier (ID) numbers. Data linking participant and household IDs to identifiable participant information will not be provided.

Publications

  • Kissock KR, Okoro C, Trieu K, Ripiye NR, Orji A, Huffman MD, Neal B, Ojji D. A feasibility study for a trial testing the effects of reduced-sodium salt on the rise in blood pressure with age. Nutr Metab Cardiovasc Dis. 2025 Oct;35(10):104129. doi: 10.1016/j.numecd.2025.104129. Epub 2025 May 11.

    PubMed 40451676

Questions about this trial

What is this clinical trial studying?

A study testing Reduced-sodium potassium-enriched salt in people with Blood Pressure, run by The George Institute at 2 sites in Nigeria.

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 4 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 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nigeria. 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?

Rate of recruitment (time frame: 2 months). The study lists 4 primary outcomes in all. 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 NCT05912426, which also lists 1 linked publication.

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 29 Aug 2024.

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