Reduced-sodium potassium-enriched salt
BehavioralSupply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride).
NCT Number: NCT05912426
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.
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Notify Me6 year and older
All sexes
Interventional
Not applicable
Gofidna, Abuja Municipal Area Council, Federal Capital Territory, Nigeria
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride).
Time frame: 2 months
Measured as the number of households recruited each month
Time frame: 2 months
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.
Time frame: 2 months
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
Time frame: 2 months
Measured as the percentage of participants that provide key data points (e.g., blood pressure, safety) at each visit
Time frame: 2 months
Measured as the number of eligible households over the number of households approached at registration visits.
Time frame: 2 months
Time frame: 2 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
Time frame: 2 months
Measured using validated and automated sphygmomanometers, according to standard practices and definitions outlined in the Global Alliance for Chronic Disease (GACD) data dictionary
Time frame: 2 months
Measured as the mmol/L of sodium from a spot urine sample
Time frame: 2 months
Measured as the mmol/L of potassium from a spot urine sample
Time frame: 2 months
The George Institute
Other
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)
Acronym: RAISED
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