Clinical trial NCT05912426: Preventing the Rise in Blood Pressure With Age Using Reduced-sodium Salt
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Reduced-sodium salt
Potassium-enriched salt
Salt reduction
Blood pressure
Salt
Feasibility
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: University of Abuja Teaching Hospital
First posted: 2023-06-22
Enrollment: 148
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of recruitment
timeFrame: 2 months
measure: Adherence to the reduced-sodium salt intervention
timeFrame: 2 months
measure: Acceptability of the reduced-sodium salt intervention
timeFrame: 2 months
measure: Completion rate of visits
timeFrame: 2 months
Secondary outcomes:
measure: Total number and percentage of households eligible to participate in the study
timeFrame: 2 months
measure: Average number of participants per household and breakdown by age group
timeFrame: 2 months
measure: Willingness to engage in monthly follow-up visits in a longer-term trial (48-months)
timeFrame: 2 months
measure: Systolic and diastolic blood pressure
timeFrame: 2 months
measure: Urinary sodium concentration
timeFrame: 2 months
measure: Urinary potassium concentration
timeFrame: 2 months
measure: Weight
timeFrame: 2 months
Other outcomes:
Locations:
city: Abuja Municipal Area Council
country: Nigeria
facility: Gofidna
state: Federal Capital Territory
city: Abuja Municipal Area Council
country: Nigeria
facility: Jahi-2
state: Federal Capital Territory
Study officials:
affiliation: The George Institute
name: Katrina Kissock, PhD
role: STUDY_CHAIR
affiliation: The George Institute
name: Bruce Neal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja Teaching Hospital
name: Dike Ojji, PhD
role: STUDY_DIRECTOR
References: