Preventing the Rise in Blood Pressure With Age Using Reduced-sodium Salt

Blood Pressure Clinical Trial

— RAISED  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05912426
• Other study ID #: HC230273
• Secondary ID: UATH/HREC/PR/202
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Behavioral:
• Reduced-sodium potassium-enriched salt
Supply and use of a reduced-sodium, potassium-enriched iodised salt (66% potassium chloride, 34% sodium chloride).

Locations

Country	Name	City	State
Nigeria	Gofidna	Abuja Municipal Area Council	Federal Capital Territory
Nigeria	Jahi-2	Abuja Municipal Area Council	Federal Capital Territory

Sponsors (2)

Lead Sponsor	Collaborator
The George Institute	University of Abuja Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recruitment	Measured as the number of households recruited each month	2 months
Primary	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
Primary	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
Primary	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	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
Secondary	Average number of participants per household and breakdown by age group		2 months
Secondary	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
Secondary	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
Secondary	Urinary sodium concentration	Measured as the mmol/L of sodium from a spot urine sample	2 months
Secondary	Urinary potassium concentration	Measured as the mmol/L of potassium from a spot urine sample	2 months
Secondary	Weight		2 months