Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program (NCT04765865) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
Nigeria1,350 participantsStarted 2023-06-26
Plain-language summary
The NaSS aims to assess the extent to which the SHAKE program is implemented within Nigeria by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC) using a type III hybrid, mixed method study design.
Who can participate
Age range
18 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female adults (aged 18 to 69 years)
* Willingness to participate
* Permanent residents (a person who has been in the household for at least 6 months) of the study area
* Ability to provide informed consent
Exclusion Criteria:
* Individuals who are unable to provide informed consent
* Pregnant women, and those who are breastfeeding and/or women menstruating at the time of collection
* Cognitively impaired adults
* Those with known history of heart or kidney failure, stroke, liver disease
* Those who recently began therapy with diuretics (less than two weeks)
* Any other conditions that would make 24-hour urine collection difficult
* Individuals who are not yet adults (minors): i.e. infants, children, or teenagers \<18 years old
* Prisoners or other detained individuals
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mean population sodium intake from baseline (Wave 1) to follow-up (Waves 2 and 3).
Timeframe: Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
2
Change in 24-hour urinary sodium from baseline (Wave 1) to follow-up (Wave 3)