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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Centro Medico Lic Adolfo Lopez Mate
Sponsor:
Information provided by (Responsible Party):
Rafael Gonzalez-Toledo, Centro Medico Lic Adolfo Lopez Mate
ClinicalTrials.gov Identifier:
NCT01981083
First received: October 30, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Centro Medico Lic Adolfo Lopez Mate:

Primary Outcome Measures:
  • Change in Malnutrition-Inflammation Score [ Time Frame: Bimonthly, up to six months ] [ Designated as safety issue: No ]
  • Change in Subjective Global Assessment [ Time Frame: Bimonthly, up to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: October 30, 2013
Last Updated: November 5, 2013
Health Authority: Mexico: Ministry of Health

Keywords provided by 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
Nutrition Disorders
Renal Insufficiency
Kidney Failure, Chronic
Protein-Energy Malnutrition
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Protein Deficiency
Deficiency Diseases

ClinicalTrials.gov processed this record on September 18, 2014