Chronic Kidney DiseaseOxCKD1NCT01552317
OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease
A study testing OxSalt care bundle in people with Chronic Kidney Disease, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- OxSalt care bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with CKD and an eGFR ≥ 20 ml/min/1.73m2
- Participant has clinically acceptable laboratory data available to confirm the diagnosis.
- Able (in the opinion of the Investigators) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Who cannot join
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Inability to understand English or special communication needs because the interventions will use English and is not funded to deal with special communication needs.
- Known salt losing nephropathy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: OxCKD1 - a Randomised Controlled Trial of the OxSalt1 Care Bundle to Help Renal Patients Learn How to Lower the Salt Content of Their Diets.
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.
Read more
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- OxSalt care bundle
- Keywords
- chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxSalt care bundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A package of advice and interventions to help participants reduce their salt intake. Receives: Other: OxSalt care bundle |
| Normal care | No intervention | This group will receive the normal care that they would get anyway. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Urinary Sodium Excretion
To evaluate whether a new care bundle helps patients to reduce their salt intake.
Measured: 1 month
24-hour Urinary Salt Excretion
Measured: 1 month
Secondary outcomes (4)
24-hour Urinary Sodium Excretion
Measured: 3 months
24-hour Urinary Salt Excretion
Measured: 3 months
24-hour Urinary Sodium Excretion
Measured: 11 months
24-hour Urinary Salt Excretion
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Renal Society
- Responsible party
- Sponsor
- Investigators
- Christopher A O'Callaghan, MD PhD, Principal investigator, University of Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552317
- Sponsor's protocol ID
- OxCKD1
- Acronym
- OxCKD1
- Status last verified
- Dec 2014
- First submitted
- 1 Mar 2012
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
O'Callaghan CA, Camidge C, Thomas R, Reschen ME, Maycock AJ, Lasserson DS, Fox RA, Thomas NPB, Shine B, James T. Evaluation of a Simple Low-cost Intervention to Empower People with CKD to Reduce Their Dietary Salt Intake: OxCKD1, a Multicenter Randomized Controlled Trial. Kidney360. 2023 Jul 1;4(7):890-898. doi: 10.34067/KID.0000000000000160. Epub 2023 May 31.
PubMed 37254243McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
PubMed 34164803
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OxCKD1 - a Randomised Controlled Trial of the OxSalt1 Care Bundle to Help Renal Patients Learn How to Lower the Salt Content of Their Diets.
- ClinicalTrials.gov ID
- NCT01552317
- Acronym / sponsor ID
- OxCKD1 / OxCKD1
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Renal Society
- Study start
- Apr 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: OxSalt care bundleA package of advice and interventions to help participants reduce their salt intake. |
| Normal care | No intervention | –This group will receive the normal care that they would get anyway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with CKD and an eGFR ≥ 20 ml/min/1.73m2
- Participant has clinically acceptable laboratory data available to confirm the diagnosis.
- Able (in the opinion of the Investigators) and willing to comply with all study requirements.
Key exclusion criteria (4 listed)
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Inability to understand English or special communication needs because the interventions will use English and is not funded to deal with special communication needs.
- Known salt losing nephropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxSalt care bundleA 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. | Other | Intervention |
Primary outcome
24-hour Urinary Sodium Excretion
Time frame: 1 month
To evaluate whether a new care bundle helps patients to reduce their salt intake.
24-hour Urinary Salt Excretion
Time frame: 1 month
4 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37254243O'Callaghan CA, Camidge C, Thomas R, Reschen ME, Maycock AJ, Lasserson DS, Fox RA, Thomas NPB, Shine B, James T. Evaluation of a Simple Low-cost Intervention to Empower People with CKD to Reduce Their Dietary Salt Intake: OxCKD1, a Multicenter Randomized Controlled Trial. Kidney360. 2023 Jul 1;4(7):890-898. doi: 10.34067/KID.0000000000000160. Epub 2023 May 31.
- Derived from this study: PubMed 34164803McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
- University of Oxford Department of Medicine websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher A O'Callaghan, MD PhD principal investigator
University of Oxford, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OxSalt care bundle in people with Chronic Kidney Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Urinary Sodium Excretion (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01552317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.