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

Centro Medico Lic Adolfo Lopez Mate

Status and phase: Unknown; Phase 4

Conditions: Hemodialysis; Protein-Energy Malnutrition; Kidney Failure, Chronic

Treatments: Dietary Supplement: Egg albumin-based protein supplement; Dietary Supplement: Renal-specific oral supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT01981083

217B500602013026

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Kidney Disease in Hemodialysis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Egg albumin-based protein supplement

Experimental group

Description:

Powder form, dosage 30 g daily, duration 6 months

Treatment:

Dietary Supplement: Egg albumin-based protein supplement

Renal-specific oral supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Renal-specific oral supplement