MedDataX Logo

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

NCT ID: NCT01981083

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Protein-Energy Malnutrition Kidney Failure, Chronic Hemodialysis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Egg albumin-based protein supplement

Powder form, dosage 30 g daily, duration 6 months

Group Type EXPERIMENTAL

Egg albumin-based protein supplement

Intervention Type DIETARY_SUPPLEMENT

Renal-specific oral supplement

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

Group Type ACTIVE_COMPARATOR

Renal-specific oral supplement

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Egg albumin-based protein supplement

Intervention Type DIETARY_SUPPLEMENT

Renal-specific oral supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pure ProEgg Enterex Renal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic Kidney Disease in Hemodialysis

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro Medico Lic Adolfo Lopez Mate

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rafael Gonzalez-Toledo

Affiliated Physician of the Nephrology Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Medico Lic. Adolfo López Mateos

Toluca, State of Mexico, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rafael Gonzalez-Toledo, MD

Role: CONTACT

Phone: 52(722)2760860

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

217B500602013026

Identifier Type: -

Identifier Source: org_study_id