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| ID | Type | Description | Link |
|---|---|---|---|
| UATH/HREC/PR/2023/06/084 | Other Identifier | University of Abuja Teaching Hospital HREC |
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| Name | Class |
|---|---|
| University of Abuja Teaching Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced-sodium potassium-enriched salt | Experimental | Reduced-sodium potassium-enriched salt |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced-sodium potassium-enriched salt | Behavioral | Supply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Average number of participants per household and breakdown by age group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrina Kissock, PhD | The George Institute | Study Chair |
| Bruce Neal, PhD | The George Institute | Principal Investigator |
| Dike Ojji, PhD | University of Abuja Teaching Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gofidna | Abuja Municipal Area Council | Federal Capital Territory | Nigeria | |||
| Jahi-2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40451676 | Derived | 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. |
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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.
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| 2 months |
| 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 | 2 months |
| 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 | 2 months |
| Urinary sodium concentration | Measured as the mmol/L of sodium from a spot urine sample | 2 months |
| Urinary potassium concentration | Measured as the mmol/L of potassium from a spot urine sample | 2 months |
| Weight | 2 months |
| Abuja Municipal Area Council |
| Federal Capital Territory |
| Nigeria |