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

November 5, 2013 updated by: Rafael Gonzalez-Toledo, Centro Medico Lic Adolfo Lopez Mate

Randomized, Open Label, Controlled Clinical Trial of Egg Albumin-Based Protein Supplement Versus Renal Specific Oral Supplement in Hemodialysis Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

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

  • Mexico
    • Estado de Mexico
      • Toluca, Estado de Mexico, Mexico, 50010
        • Centro Medico Lic. Adolfo López Mateos

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic Kidney Disease in Hemodialysis

Exclusion Criteria:

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Enterex Renal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Malnutrition-Inflammation Score
Time Frame: Bimonthly, up to six months
Bimonthly, up to six months
Change in Subjective Global Assessment
Time Frame: Bimonthly, up to six months
Bimonthly, up to six months

Collaborators and Investigators

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

Sponsor

Centro Medico Lic Adolfo Lopez Mate

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

November 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (ESTIMATE)

November 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217B500602013026

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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