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)

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Behavioral: Reduced-sodium potassium-enriched salt

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Federal Capital Territory
    • Abuja Municipal Area Council, Federal Capital Territory, Nigeria
      • Gofidna
    • Abuja Municipal Area Council, Federal Capital Territory, Nigeria
      • Jahi-2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced-sodium potassium-enriched salt	Behavioral: Reduced-sodium potassium-enriched salt; Supply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: The George Institute
• Collaborators: University of Abuja Teaching Hospital
• Investigators: Principal Investigator: Bruce Neal, PhD, The George Institute; Study Chair: Katrina Kissock, PhD, The George Institute; Study Director: Dike Ojji, PhD, University of Abuja Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility; Blood pressure; Salt; Salt reduction; Reduced-sodium salt; Potassium-enriched salt
• Other Study ID Numbers: HC230273; UATH/HREC/PR/2023/06/084 (Other Identifier: University of Abuja Teaching Hospital HREC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No