Clinical Trials Directory

Trials / Unknown

UnknownNCT03979534

Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Centre Hospitalier le Mans · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.

Detailed description

The recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). This strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. In high comorbidity patients, survival is not necessarily improved by dialysis. Nutritional care, adapted to each patient's needs and preferences, could in part answer these demands. Indeed, renal function has a strict correlation with dietary patterns. Low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). In dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status. The study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients' needs.

Conditions

Interventions

TypeNameDescription
OTHERlow protein dietPatients will be managed with a restricted protein intake (controlled protein diets with a mean target at 0.6 g / kg / day of protein, according to a choice of dietary approaches, adapted to the situation of each patient).

Timeline

Start date
2019-04-02
Primary completion
2023-04-02
Completion
2023-04-02
First posted
2019-06-07
Last updated
2022-03-09

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03979534. Inclusion in this directory is not an endorsement.