OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease

NCT01552317 | Completed Results

• 1 other identifier: OxCKD1
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (2)

• 24-hour Urinary Sodium Excretion

  To evaluate whether a new care bundle helps patients to reduce their salt intake.

  1 month

• 24-hour Urinary Salt Excretion

  1 month

Secondary Outcomes (4)

• 24-hour Urinary Sodium Excretion

  3 months

• 24-hour Urinary Salt Excretion

  3 months

• 24-hour Urinary Sodium Excretion

  11 months

• 24-hour Urinary Salt Excretion

  11 months

Study Arms (2)

Intervention

EXPERIMENTAL

A package of advice and interventions to help participants reduce their salt intake.

Other: OxSalt care bundle

Normal care

NO INTERVENTION

This group will receive the normal care that they would get anyway.

Interventions

OxSalt care bundle OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• British Renal Society: collaborator

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37254243 DERIVED

• McMahon 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.

  PMID: 34164803 DERIVED

Related Links

• University of Oxford Department of Medicine website
• British Renal Society

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Oxford

chris.ocallaghan@ndm.ox.ac.uk

+441865287794

Study Officials

• Christopher A O'Callaghan, MD PhD

  University of Oxford, UK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 13, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2014-12

Locations

GB (1)