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

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ClinicalTrials.gov Identifier: NCT01946841
Recruitment Status : Withdrawn (No Patient recruitment)
First Posted : September 20, 2013
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Renal Failure Chronic Requiring Hemodialysis Severe Malnutrition Tolerance Quality of Life Activity Appetite and General Nutritional Disorders Dietary Supplement: RealDiet®Renal Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.
Study Start Date : August 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: RealDiet®Renal enteral nutrition Dietary Supplement: RealDiet®Renal


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment. [ Time Frame: 6 months ]
  2. Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment. [ Time Frame: 6 months ]
  3. Evolution of tolerance of study product during 3 months of enteral nutrition. [ Time Frame: 3 mois ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946841


Locations
France
Lactalis
Retiers, France, 35240
Sponsors and Collaborators
Lactalis
Clinact
More Information

Responsible Party: Lactalis
ClinicalTrials.gov Identifier: NCT01946841     History of Changes
Other Study ID Numbers: LRD - 2013 - ALENPHED
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: September 2013

Keywords provided by Lactalis:
Chronic kidney disease
Hemodialysis
Severe malnutrition
Enteral nutrition

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Malnutrition
Kidney Failure, Chronic
Nutrition Disorders
Urologic Diseases