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

NCT01981083 | Unknown Phase 4 DMC

• 1 other identifier: 217B500602013026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Protein-Energy Malnutrition; Kidney Failure, Chronic; Hemodialysis

Keywords

Protein-Energy Malnutrition; Chronic Kidney Disease; Malnutrition-Inflammation Score; Subjective Global Assessment; Hemodialysis; Egg albumin

Outcome Measures

Primary Outcomes (2)

• Change in Malnutrition-Inflammation Score

  Bimonthly, up to six months

• Change in Subjective Global Assessment

  Bimonthly, up to six months

Study Arms (2)

Egg albumin-based protein supplement

EXPERIMENTAL

Powder form, dosage 30 g daily, duration 6 months

Dietary Supplement: Egg albumin-based protein supplement

Renal-specific oral supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Renal-specific oral supplement

Interventions

Egg albumin-based protein supplement DIETARY_SUPPLEMENT

Also known as: Pure ProEgg

Egg albumin-based protein supplement

Renal-specific oral supplement DIETARY_SUPPLEMENT

Also known as: Enterex Renal

Renal-specific oral supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Kidney Disease in Hemodialysis

You may not qualify if:

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

Sponsors & Collaborators

• Centro Medico Lic Adolfo Lopez Mate: lead

Study Sites (1)

Centro Medico Lic. Adolfo López Mateos

Toluca, State of Mexico, 50010, Mexico

Location

MeSH Terms

Conditions

Protein-Energy Malnutrition; Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rafael Gonzalez-Toledo, MD

CONTACT

52(722)2760860; rtoledo29@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Physician of the Nephrology Service

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2014
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

ME (1)