Preventing the Rise in Blood Pressure With Age Using Reduced-sodium Salt
RAISED
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)
2 other identifiers
interventional
148
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2024
CompletedAugust 29, 2024
August 1, 2024
3 months
May 31, 2023
August 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Rate of recruitment
Measured as the number of households recruited each month
2 months
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.
2 months
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
2 months
Completion rate of visits
Measured as the percentage of participants that provide key data points (e.g., blood pressure, safety) at each visit
2 months
Secondary Outcomes (7)
Total number and percentage of households eligible to participate in the study
2 months
Average number of participants per household and breakdown by age group
2 months
Willingness to engage in monthly follow-up visits in a longer-term trial (48-months)
2 months
Systolic and diastolic blood pressure
2 months
Urinary sodium concentration
2 months
- +2 more secondary outcomes
Study Arms (1)
Reduced-sodium potassium-enriched salt
EXPERIMENTALReduced-sodium potassium-enriched salt
Interventions
Supply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institutelead
- University of Abuja Teaching Hospitalcollaborator
Study Sites (2)
Gofidna
Abuja Municipal Area Council, Federal Capital Territory, Nigeria
Jahi-2
Abuja Municipal Area Council, Federal Capital Territory, Nigeria
Related Publications (1)
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.
PMID: 40451676DERIVED
Study Officials
- STUDY CHAIR
Katrina Kissock, PhD
The George Institute
- PRINCIPAL INVESTIGATOR
Bruce Neal, PhD
The George Institute
- STUDY DIRECTOR
Dike Ojji, PhD
University of Abuja Teaching Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 22, 2023
Study Start
March 5, 2024
Primary Completion
May 20, 2024
Study Completion
May 20, 2024
Last Updated
August 29, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
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.