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

NCT ID: NCT03979534

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2023-04-02

Brief 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

Chronic Kidney Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Diet group

Diet follow-up to personalize a low-protein diet for each patient. All patients following a low protein diet one month or more compose the "diet group".

Group Type: EXPERIMENTAL

low protein diet

Intervention Type: OTHER

Patients 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).

Control group

Patients who accepted to take part of the study but refused the low protein diet and patients who discontinued the diet on the first month compose the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

low protein diet

Patients 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All adult patients followed on the unit for advanced CKD, with Kidney disease stage 4-5 or stage 3 with fast progression and without contraindications.

Exclusion Criteria

• Malnutrition or short life-expectancy
• Patients aged less than 18 years old
• Pregnant women,
• Incapacity to complete the free-consent form,
• Pateints refusing participation in the study,
• Patients without healthcare coverage.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giorgina Piccoli, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Mans

Locations

Centre Hospitalier Le Mans

Le Mans, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christelle Jadeau, PD

Role: CONTACT

cjadeau@ch-lemans.fr

0 (33) 2 43 43 43 43 ext. 37 482

Facility Contacts

Christelle Jadeau, PD

Role: primary

cjadeau@ch-lemans.fr

0 (33) 2 43 43 43 43 ext. 37 482

Other Identifiers

CHM-2016-S8/05

Identifier Type: -

Identifier Source: org_study_id