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

Primary Purpose

Protein-Energy Malnutrition, Kidney Failure, Chronic, Hemodialysis

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Egg albumin-based protein supplement
Renal-specific oral supplement
Sponsored by
Centro Medico Lic Adolfo Lopez Mate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein-Energy Malnutrition focused on measuring Protein-Energy Malnutrition, Chronic Kidney Disease, Malnutrition-Inflammation Score, Subjective Global Assessment, Hemodialysis, Egg albumin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic Kidney Disease in Hemodialysis

Exclusion Criteria:

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

Sites / Locations

  • Centro Medico Lic. Adolfo López Mateos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Egg albumin-based protein supplement

Renal-specific oral supplement

Arm Description

Powder form, dosage 30 g daily, duration 6 months

Liquid form, dosage 237 ml (one can) daily, duration 6 months

Outcomes

Primary Outcome Measures

Change in Malnutrition-Inflammation Score
Change in Subjective Global Assessment

Secondary Outcome Measures

Full Information

First Posted
October 30, 2013
Last Updated
November 5, 2013
Sponsor
Centro Medico Lic Adolfo Lopez Mate
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1. Study Identification

Unique Protocol Identification Number
NCT01981083
Brief Title
Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients
Official Title
Randomized, Open Label, Controlled Clinical Trial of Egg Albumin-Based Protein Supplement Versus Renal Specific Oral Supplement in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Medico Lic Adolfo Lopez Mate

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-Energy Malnutrition, Kidney Failure, Chronic, Hemodialysis
Keywords
Protein-Energy Malnutrition, Chronic Kidney Disease, Malnutrition-Inflammation Score, Subjective Global Assessment, Hemodialysis, Egg albumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Egg albumin-based protein supplement
Arm Type
Experimental
Arm Description
Powder form, dosage 30 g daily, duration 6 months
Arm Title
Renal-specific oral supplement
Arm Type
Active Comparator
Arm Description
Liquid form, dosage 237 ml (one can) daily, duration 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Egg albumin-based protein supplement
Other Intervention Name(s)
Pure ProEgg
Intervention Type
Dietary Supplement
Intervention Name(s)
Renal-specific oral supplement
Other Intervention Name(s)
Enterex Renal
Primary Outcome Measure Information:
Title
Change in Malnutrition-Inflammation Score
Time Frame
Bimonthly, up to six months
Title
Change in Subjective Global Assessment
Time Frame
Bimonthly, up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Kidney Disease in Hemodialysis Exclusion Criteria: Infection Liver insufficiency Cancer or neoplasia Acquired immunodeficiency syndrome Intestinal malabsorption syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Gonzalez-Toledo, MD
Phone
52(722)2760860
Ext
90457
Email
rtoledo29@yahoo.com.mx
Facility Information:
Facility Name
Centro Medico Lic. Adolfo López Mateos
City
Toluca
State/Province
Estado de Mexico
ZIP/Postal Code
50010
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Gonzalez-Toledo, MD

12. IPD Sharing Statement

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

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