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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01981083
• Other study ID #: 217B500602013026
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 30, 2013
• Last updated: November 5, 2013
• Start date: November 2013

Study information

• Verified date: November 2013
• Source: Centro Medico Lic Adolfo Lopez Mate
• Contact: Rafael Gonzalez-Toledo, MD
• Phone: 52(722)2760860
• Email: rtoledo29[@]yahoo.com.mx
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic Kidney Disease in Hemodialysis

Exclusion Criteria:

• Infection

• Liver insufficiency

• Cancer or neoplasia

• Acquired immunodeficiency syndrome

• Intestinal malabsorption syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Kidney Failure, Chronic
• Malnutrition
• Protein-Energy Malnutrition
• Renal Insufficiency

Intervention

Dietary Supplement:
• Egg albumin-based protein supplement

• Renal-specific oral supplement

Locations

Country	Name	City	State
Mexico	Centro Medico Lic. Adolfo López Mateos	Toluca	Estado de Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Lic Adolfo Lopez Mate

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Malnutrition-Inflammation Score		Bimonthly, up to six months	No
Primary	Change in Subjective Global Assessment		Bimonthly, up to six months	No