Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life (AL-EN-PHED)

April 16, 2015 updated by: Lactalis

Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.

The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Retiers, France, 35240
        • Lactalis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week
  • Patients aged 18 years
  • Written, free and informed consent given by the Patient
  • Patient insured under the social security system or equivalent
  • Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion

  • Patient in a state of malnutrition

    • defined by the presence of at least 3 out of 5 of the following criteria :

      • weight loss greater than 10% observed in the last six months
      • serum albumin <35 g / l
      • serum Prealbumin <300 mg / l
      • BMI <20
      • NPNA <1 g / kg / day for 2 consecutive months

and

  • presenting

    • food intake <20 kcal / kg / day or
    • failure of other nutritional care methods, namely, oral nutritional supplements and / or peridialytic parenteral nutrition, or total parenteral nutrition
    • lack of compliance after one month, to the nutritional care methods mentioned above. • Patients for whom the decision to prescribe enteral feeding was previously taken

Exclusion Criteria:

  • Patients with a history of intolerance to enteral feeding
  • Index Kt/Veq (balanced) < or = 1.2 or index Kt/Vsp (single pool) < or = 1.4 according to the method used
  • Patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase)
  • Pregnant Patient
  • Patient with a known allergy to at least one of the following : milk protein, soy, fish
  • Patient whose digestive tract is not functional or patient in shock
  • Patient protected under guardianship
  • Patient in exclusion period after participation in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RealDiet®Renal enteral nutrition
Dietary supplement: RealDiet®Renal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of serum prealbumin and albumin.
Time Frame: 6 months
Evaluate during 3 months specific enteral nutrition (SEN) treatment, and 3 months after treatment interruption, the effects of the study product on the evolution of serum prealbumin and albumin.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.
Time Frame: 6 months
6 months
Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.
Time Frame: 6 months
6 months
Evolution of tolerance of study product during 3 months of enteral nutrition.
Time Frame: 3 mois
3 mois

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lactalis

Collaborators

Clinact

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

September 17, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRD - 2013 - ALENPHED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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