Wellbeing intervention for chronic kidney disease (WICKD): a randomised controlled trial study protocol

IntroductionChronic kidney disease (CKD) causes severe disturbances in phosphate metabolism. New Nordic Renal Diet (NNRD) is a new dietary concept designed by the present research group that aims to offer patients with moderate CKD a whole food approach with a markedly reduction in dietary phosphorus intake, corresponding to 850 mg/day. The present protocol describes a randomised controlled trial aiming to test the long-term effects of dietary intervention with NNRD versus a non-restricted habitual diet on important parameters of phosphorus and lipid homeostasis.Methods and analysisThis trial will be executed at the Department of Nephrology, Rigshospitalet, University of Copenhagen, Denmark. Sixty patients aged >18 years with CKD stages 3 and 4 (estimated glomerular filtration rate between 15 and 45 mL/min) will be recruited and randomly assigned to the intervention or control group. The other inclusion criterion includes a medically stable condition for at least 2 months prior to the start of the study. Exclusion criteria are treatment with phosphate binders, metabolic disorders that require specific dietary regulation, pregnancy and breast feeding, any types of food allergies or those who are vegans. The observation period is 26 weeks including seven study visits at the outpatient clinic combined with a weekly telephone consultation in both groups. A follow-up visit 3 months after study completion finalises the intervention. The primary outcome is the difference in the change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups. Secondary outcomes include changes in phosphate-related and lipid metabolism-related blood and urine biochemistry, blood pressure and body composition. Moreover, we wish to explore adherence to the diet as well as quality of life.Ethics and disseminationThe study has been approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. The results of the studies will be presented at national and international scientific meetings, and publications will be submitted to peer-reviewed journals.Trial registration numberClinicalTrials.gov (wwwclinicaltrialsgov) Registry (NCT04579315).Protocol versionThe protocol, version 2, has been approved by the Ethical Committee Denmark on 18 September 2020. The protocol has also been approved by Data Protection Regulation and Data Protection Law on 15 September 2020. This study protocol is in accordance with the Standard Protocol Items: Recommendations for International Trials.

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Faculty Opinions recommendation of The role of salt intake and salt sensitivity in the management of hypertension in South Asian people with chronic kidney disease: a randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718019587.793481659 ◽

2013 ◽

Author(s):

David Goldsmith

Keyword(s):

Chronic Kidney Disease ◽

Randomised Controlled Trial ◽

Kidney Disease ◽

South Asian ◽

Salt Intake ◽

Controlled Trial ◽

Salt Sensitivity ◽

Randomised Controlled ◽

Asian People

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Comparison of efficacy and safety between benidipine and hydrochlorothiazide in fosinopril-treated hypertensive patients with chronic kidney disease: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2016-013672 ◽

2017 ◽

Vol 7 (2) ◽

pp. e013672

Author(s):

Cheng Xue ◽

Chenchen Zhou ◽

Bo Yang ◽

Jiayi Lv ◽

Bing Dai ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Randomised Controlled Trial ◽

Kidney Disease ◽

Controlled Trial ◽

Efficacy And Safety ◽

Hypertensive Patients ◽

Randomised Controlled

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P.64 Active Vitamin D Treatment Does Not Improve Arterial Stiffness and Markers of Cardio-Renal Risk in Patients with Type 2 Diabetes and Stage 3 Chronic Kidney Disease: a Randomised Controlled Trial

Artery Research ◽

10.2991/artres.k.201209.073 ◽

2020 ◽

Vol 26 (Supplement 1) ◽

pp. S88

Author(s):

Nikolaos Fountoulakis ◽

Salma Ayis ◽

Anastasios Mangelis ◽

Angeliki Panagiotou ◽

Maria Flaquer ◽

...

Keyword(s):

Type 2 Diabetes ◽

Chronic Kidney Disease ◽

Vitamin D ◽

Randomised Controlled Trial ◽

Kidney Disease ◽

Arterial Stiffness ◽

Controlled Trial ◽

Active Vitamin ◽

Randomised Controlled

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The EX-FRAIL CKD trial: a study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease

BMJ Open ◽

10.1136/bmjopen-2019-035344 ◽

2020 ◽

Vol 10 (6) ◽

pp. e035344

Author(s):

Andrew Christopher Nixon ◽

Theodoros M Bampouras ◽

Helen J Gooch ◽

Hannah M L Young ◽

Kenneth William Finlayson ◽

...

Keyword(s):

Older Adults ◽

Chronic Kidney Disease ◽

Randomised Controlled Trial ◽

Kidney Disease ◽

Outcome Measures ◽

Controlled Trial ◽

Exercise Programme ◽

Frailty Status ◽

Home Based ◽

Randomised Controlled

IntroductionFrailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD.Methods and analysisThe EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2).Ethics and disseminationEthical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body.Trial registration numberISRCTN87708989.

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