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OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease (OxCKD1)

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ClinicalTrials.gov Identifier: NCT01552317
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : December 3, 2014
British Renal Society
Information provided by (Responsible Party):
University of Oxford

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: OxSalt care bundle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Study Start Date : April 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: lifestyle counselling
A package of advice and interventions to help participants reduce their salt intake.
Other: OxSalt care bundle
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.

No Intervention: Normal care
This group will receive the normal care that they would get anyway.

Primary Outcome Measures :
  1. Salt intake [ Time Frame: 1 month ]
    To evaluate whether a new care bundle helps patients to reduce their salt intake.

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 1 month, 3 months, 11 months ]
    To assess the effects of the new care bundle on blood pressure.

  2. urine protein [ Time Frame: 1 month, 3 months, 11 months ]
    To assess the effects of the new care bundle on urine albumin and protein levels.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552317

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United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
British Renal Society
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Principal Investigator: Christopher A O'Callaghan, MD PhD University of Oxford, UK
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01552317    
Other Study ID Numbers: OxCKD1
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by University of Oxford:
chronic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency