An interventional study of High water intake and Ad libitum water intake in Autosomal Dominant Polycystic Kidney Disease, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.
Autosomal Dominant Polycystic Kidney Disease (PKD) affects 12.5 million people worldwide, and accounts for 7% of those requiring renal replacement therapy. The hormone vasopressin drives cyst growth until ultimately most of the normal functioning kidney tissue is replaced and compressed by cysts over the life course. Half of those affected will require dialysis by the age of 55 years.
Vasopressin blockade has emerged as a viable strategy for altering disease course. High water intake suppresses vasopressin, and may therefore slow cyst growth and consequent disease progression. However, evidence to support high water intake in PKD is lacking, and it is not clear whether patients can adhere sufficiently to a high water intake.
DRINK is a single-centre prospective, open label, parallel group randomised controlled feasibility trial. The primary objective is to establish whether a definitive large randomised trial comparing high versus ad libitum water intake on long-term disease progression is deliverable. Fifty patients will be recruited from the Renal Genetics service at Addenbrooke's Hospital. Participants will be randomly allocated to the high water intake (high) or the ad libitum (standard) water intake group. For the high intake group the aim is to drink large enough volumes of water to achieve and maintain dilute urine (urine osmolality \< 270 mOsmo/kg or urine specific gravity ≤ 1.010 ). Multiple methods will be employed to promote adherence these include instruction and education as well as self-monitoring of urine specific gravity twice weekly by participants and the recording of results via a trial specific smartphone application.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 42 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 167 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ad libitum water intake, defined as intake guided by thirst to achieve a target urine osmolality \> 300 mOsmo/kg
Other: Ad libitum water intake
Personalised daily water intake prescription to achieve target urine osmolality \< 270 mOsm/kg.
Dietary Supplement: High water intake
High water intake aimed at achieving an urine osmolality \< 270mOsmo/kg. Individualised prescription for each participant based on the free water clearance formula calculation.
Water intake guided by thirst
The proportion of patients achieving a urine osmolality < 270 mOsm/kg
Time frame: 8 weeks
Urine osmolality
Achieved urine osmolality as a surrogate for vasopressin suppression
Time frame: 8 weeks
Proportion of participants that can self-monitor and report urine specific gravity reliably
Time frame: 8 weeks
Proportion of patients experiencing a serious adverse event
Time frame: 12 weeks
Acute change in estimated GFR
Evaluation of the change form baseline eGFR after 2 weeks
Time frame: 4 weeks
Health-Related Quality of Life (HRQoL)
Change from baseline HRQoL as estimated by EQ5D-5L
Time frame: 12 weeks
Recruitment rate
Time frame: 8 weeks
Plan to share: Yes
This study is completed, as verified in Jan 2019. 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.
Cambridge University Hospitals NHS Foundation Trust