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Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01981083
Recruitment Status : Unknown
Verified November 2013 by Rafael Gonzalez-Toledo, Centro Medico Lic Adolfo Lopez Mate.
Recruitment status was:  Not yet recruiting
First Posted : November 11, 2013
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
Rafael Gonzalez-Toledo, Centro Medico Lic Adolfo Lopez Mate

Brief Summary:

Malnutrition is seen frequently in hemodialysis units in most developing countries. Malnutrition increases morbidity and mortality in this population and its treatment improves patient survival and health status The purpose of this study is to compare two strategies to improve nutritional status in hemodialysis patients: renal-specific oral supplement (237 ml) versus egg albumin-based protein supplement (30 g) on a daily basis.

This trial uses the Malnutrition Inflammation Score (MIS) and Subjective Global Assessment (SGA) in addition to most used biochemical markers to determine nutritional status.


Condition or disease Intervention/treatment Phase
Protein-Energy Malnutrition Kidney Failure, Chronic Hemodialysis Dietary Supplement: Egg albumin-based protein supplement Dietary Supplement: Renal-specific oral supplement Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open Label, Controlled Clinical Trial of Egg Albumin-Based Protein Supplement Versus Renal Specific Oral Supplement in Hemodialysis Patients
Study Start Date : November 2013
Estimated Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egg albumin-based protein supplement
Powder form, dosage 30 g daily, duration 6 months
Dietary Supplement: Egg albumin-based protein supplement
Other Name: Pure ProEgg

Active Comparator: Renal-specific oral supplement
Liquid form, dosage 237 ml (one can) daily, duration 6 months
Dietary Supplement: Renal-specific oral supplement
Other Name: Enterex Renal




Primary Outcome Measures :
  1. Change in Malnutrition-Inflammation Score [ Time Frame: Bimonthly, up to six months ]
  2. Change in Subjective Global Assessment [ Time Frame: Bimonthly, up to six months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Kidney Disease in Hemodialysis

Exclusion Criteria:

  • Infection
  • Liver insufficiency
  • Cancer or neoplasia
  • Acquired immunodeficiency syndrome
  • Intestinal malabsorption syndrome

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): NCT01981083


Contacts
Contact: Rafael Gonzalez-Toledo, MD 52(722)2760860 ext 90457 rtoledo29@yahoo.com.mx

Locations
Mexico
Centro Medico Lic. Adolfo López Mateos Not yet recruiting
Toluca, Estado de Mexico, Mexico, 50010
Principal Investigator: Rafael Gonzalez-Toledo, MD         
Sponsors and Collaborators
Centro Medico Lic Adolfo Lopez Mate

Responsible Party: Rafael Gonzalez-Toledo, Affiliated Physician of the Nephrology Service, Centro Medico Lic Adolfo Lopez Mate
ClinicalTrials.gov Identifier: NCT01981083     History of Changes
Other Study ID Numbers: 217B500602013026
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Keywords provided by Rafael Gonzalez-Toledo, Centro Medico Lic Adolfo Lopez Mate:
Protein-Energy Malnutrition
Chronic Kidney Disease
Malnutrition-Inflammation Score
Subjective Global Assessment
Hemodialysis
Egg albumin

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