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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01981083
Enrollment
60
Registered
2013-11-11
Start date
2013-11-30
Completion date
Unknown
Last updated
2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Kidney Failure, Chronic, Protein-Energy Malnutrition

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTEgg albumin-based protein supplement
DIETARY_SUPPLEMENTRenal-specific oral supplement

Sponsors

Centro Medico Lic Adolfo Lopez Mate
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Chronic Kidney Disease in Hemodialysis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in Malnutrition-Inflammation ScoreBimonthly, up to six months
Change in Subjective Global AssessmentBimonthly, up to six months

Countries

Mexico

Contacts

Primary ContactRafael Gonzalez-Toledo, MD
rtoledo29@yahoo.com.mx52(722)2760860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026