Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

Quality of Life Clinical Trial

— AL-EN-PHED  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01946841
• Other study ID #: LRD - 2013 - ALENPHED
• Status: Withdrawn
• Phase: Phase 2
• First received: August 6, 2013
• Last updated: April 16, 2015
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2013
• Source: Lactalis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Activity
• Appetite and General Nutritional Disorders
• Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Malnutrition
• Nutrition Disorders
• Quality of Life
• Renal Failure Chronic Requiring Hemodialysis
• Renal Insufficiency, Chronic
• Severe Malnutrition
• Tolerance

Intervention

Dietary Supplement:
• RealDiet®Renal

Locations

Country	Name	City	State
France	Lactalis	Retiers

Sponsors (2)

Lead Sponsor	Collaborator
Lactalis	Clinact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of serum prealbumin and albumin.	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	Yes
Secondary	Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.		6 months	No
Secondary	Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.		6 months	No
Secondary	Evolution of tolerance of study product during 3 months of enteral nutrition.		3 mois	Yes