An interventional study of OxSalt care bundle in Chronic Kidney Disease, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
Patients with kidney disease benefit from reducing the amount of salt in the food that they eat. The benefits include lower blood pressure and better kidney function. Therefore, lowering the amount of salt that is eaten could reduce the number of people who will develop kidney failure. The effect on blood pressure could also reduce the number of strokes and heart attacks. Similar benefits are also seen for people without kidney disease.
Guidelines for patients with kidney disease recommend that they lower the amount of salt that they eat, but most patients do not manage to do this. The reasons for this are not unclear, but are likely to reflect the difficulty that patients have in reducing the amount of salt in their food and the nature of the advice that they are given.
The investigators have developed a package of interventions to help patients to make healthier choices that will lower their salt intake. The package helps patients to learn about salt in food and how to avoid it. It provide practical advice on cutting down on salt using information booklets, text messages, emails, telephone calls, and a website.
Participants will be recruited from hospital kidney clinics and general practice. The investigators will randomly allocate participants to receive either the normal care that they would get or to receive the new package of interventions to help them lower salt. The package of interventions will involve patients receiving text messages, telephone calls, emails and written information. They will complete a questionnaire and collect urine samples which will can be used to measure the amount of salt that they are eating. No more than 6 visits will be required. The study is funded by the British Renal Society which is a charity that funds research to help patients with kidney disease.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 201 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A package of advice and interventions to help participants reduce their salt intake.
Other: OxSalt care bundle
This group will receive the normal care that they would get anyway.
A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
24-hour Urinary Sodium Excretion
To evaluate whether a new care bundle helps patients to reduce their salt intake.
Time frame: 1 month
24-hour Urinary Salt Excretion
Time frame: 1 month
24-hour Urinary Sodium Excretion
Time frame: 3 months
24-hour Urinary Salt Excretion
Time frame: 3 months
24-hour Urinary Sodium Excretion
Time frame: 11 months
24-hour Urinary Salt Excretion
Time frame: 11 months
| Milestone | Intervention | Normal Care |
|---|---|---|
| Started | 96 | 97 |
| Completed | 77 | 81 |
| Not completed | 19 | 16 |
To evaluate whether a new care bundle helps patients to reduce their salt intake.
| mmol/day | Intervention | Normal Care |
|---|---|---|
| 24-hour Urinary Sodium Excretion | 93 ± 48 | 119 ± 52 |
| grams/ day | Intervention | Normal Care |
|---|---|---|
| 24-hour Urinary Salt Excretion | 5.4 ± 2.8 | 6.9 ± 3.1 |
| mmol/day | Intervention | Normal Care |
|---|---|---|
| 24-hour Urinary Sodium Excretion | 100 ± 41 | 113 ± 52 |
| grams/ day | Intervention | Normal Care |
|---|---|---|
| 24-hour Urinary Salt Excretion | 5.9 ± 2.4 | 6.6 ± 3.1 |
| mmol/day | Intervention | Normal Care |
|---|---|---|
| 24-hour Urinary Sodium Excretion | 106 ± 41 | 121 ± 58 |
| grams/ day | Intervention | Normal Care |
|---|---|---|
| 24-hour Urinary Salt Excretion | 6.2 ± 2.4 | 7.1 ± 3.4 |
Collected over Adverse event data were collected during the primary study period which was from the date of consent to the end of the one month period during which participants were either randomized to the intervention or to normal routine care (the control group). Further adverse event data was also collected from those participants who attended for further invited assessments at 3 or 11 months following randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| Normal Care | 0/97 (0%) | 0/97 (0%) | 0/97 (0%) |
| Age, Continuous(years) | Intervention | Normal Care | Total |
|---|---|---|---|
| Mean | 63.3 ± 12.8 | 64.2 ± 10.5 | 63.7 ± 11.7 |
| Sex: Female, Male(Participants) | Intervention | Normal Care | Total |
|---|---|---|---|
| Female | 49 | 48 | 97 |
| Male | 47 | 49 | 96 |
| Race/Ethnicity, Customized(Participants) | Intervention | Normal Care | Total |
|---|---|---|---|
| African | 2 | 0 | 2 |
| Any other Asian background | 1 | 0 | 1 |
| Any other ethnic group | 0 | 1 | 1 |
| Any other mixed background | 1 | 1 | 2 |
| Any other White background | 5 | 3 | 8 |
| British | 84 | 86 | 170 |
| Caribbean | 0 | 2 | 2 |
| Irish | 2 | 2 | 4 |
| Pakistani | 1 | 0 | 1 |
| White and Asian | 0 | 1 | 1 |
| White and Black African | 0 | 1 | 1 |
| Region of Enrollment(participants) | Intervention | Normal Care | Total |
|---|---|---|---|
| United Kingdom | 96 | 97 | 193 |
| 24-hour urinary sodium excretion(mmol/day) | Intervention | Normal Care | Total |
|---|---|---|---|
| Mean | 125 ± 53 | 134 ± 58 | 129 ± 56 |
| 24-hour urinary salt excretion(grams/ day) | Intervention | Normal Care | Total |
|---|---|---|---|
| Mean | 7.3 ± 3.1 | 7.8 ± 3.4 | 7.6 ± 3.3 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Oxford