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

Phase 4

• Conditions: Protein-Energy Malnutrition; Hemodialysis; Kidney Failure, Chronic
• Interventions: Dietary Supplement: Egg albumin-based protein supplement; Dietary Supplement: Renal-specific oral supplement

• Registration Number: NCT01981083
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-30
• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-05
• Last Update Submitted: 2013-11-05
• Study First Posted: 2013-11-11
• Last Update Posted: 2013-11-11
• Primary Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Chronic Kidney Disease in Hemodialysis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Egg albumin-based protein supplement	Egg albumin-based protein supplement	Powder form, dosage 30 g daily, duration 6 months
Renal-specific oral supplement	Renal-specific oral supplement	Liquid form, dosage 237 ml (one can) daily, duration 6 months

Primary Outcome Measures

Name	Time	Method
Change in Malnutrition-Inflammation Score	Bimonthly, up to six months
Change in Subjective Global Assessment	Bimonthly, up to six months

Trial Locations

Locations (1)

Centro Medico Lic. Adolfo López Mateos; 🇲🇽 Toluca, Estado de Mexico, Mexico