- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01981083
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
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Rafael Gonzalez-Toledo, MD
- Phone Number: 90457 52(722)2760860
- Email: rtoledo29@yahoo.com.mx
Study Locations
-
-
Estado de Mexico
-
Toluca, Estado de Mexico, Mexico, 50010
- Centro Medico Lic. Adolfo López Mateos
-
Principal Investigator:
- Rafael Gonzalez-Toledo, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic Kidney Disease in Hemodialysis
Exclusion Criteria:
- Infection
- Liver insufficiency
- Cancer or neoplasia
- Acquired immunodeficiency syndrome
- Intestinal malabsorption syndrome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Egg albumin-based protein supplement
Powder form, dosage 30 g daily, duration 6 months
|
Other Names:
|
ACTIVE_COMPARATOR: Renal-specific oral supplement
Liquid form, dosage 237 ml (one can) daily, duration 6 months
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Malnutrition-Inflammation Score
Time Frame: Bimonthly, up to six months
|
Bimonthly, up to six months
|
Change in Subjective Global Assessment
Time Frame: Bimonthly, up to six months
|
Bimonthly, up to six months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 217B500602013026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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