Protein-Energy MalnutritionPhase 4NCT01981083
Egg Albumin-Based Protein Supplement Versus Renal-specific Supplement in Hemodialysis Patients
A Phase 4 study testing Egg albumin-based protein supplement and Renal-specific oral supplement in people with Protein-Energy Malnutrition and Kidney Failure, Chronic, run by Centro Medico Lic Adolfo Lopez Mate at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Protein-Energy Malnutrition, Kidney Failure, Chronic, Hemodialysis
- What is being tested?
- Egg albumin-based protein supplement and Renal-specific oral supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Kidney Disease in Hemodialysis
Who cannot join
- Infection
- Liver insufficiency
- Cancer or neoplasia
- Acquired immunodeficiency syndrome
- Intestinal malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Medico Lic. Adolfo López Mateos
Toluca, State of Mexico, 50010
Rafael Gonzalez-Toledo, MD
About this study
Official title: 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.
- Being tested
- Egg albumin-based protein supplement, Renal-specific oral supplement
- Keywords
- Protein-Energy Malnutrition, Chronic Kidney Disease, Malnutrition-Inflammation Score, Subjective Global Assessment, Hemodialysis, Egg albumin
- Medical subject headings
- Protein-Energy Malnutrition, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg albumin-based protein supplementDietary supplement
Also called Pure ProEgg
Renal-specific oral supplementDietary supplement
Also called Enterex Renal
| Study group | Role | What they receive |
|---|---|---|
| Egg albumin-based protein supplement | Experimental | Powder form, dosage 30 g daily, duration 6 months Receives: Dietary Supplement: Egg albumin-based protein supplement |
| Renal-specific oral supplement | Active comparator | Liquid form, dosage 237 ml (one can) daily, duration 6 months Receives: Dietary Supplement: Renal-specific oral supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Malnutrition-Inflammation Score
Measured: Bimonthly, up to six months
Change in Subjective Global Assessment
Measured: Bimonthly, up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein-Energy MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Lic Adolfo Lopez Mate
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rafael Gonzalez-Toledo, Centro Medico Lic Adolfo Lopez Mate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981083
- Sponsor's protocol ID
- 217B500602013026
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Controlled Clinical Trial of Egg Albumin-Based Protein Supplement Versus Renal Specific Oral Supplement in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01981083
- Acronym / sponsor ID
- 217B500602013026
- Keywords
- Protein-Energy Malnutrition, Chronic Kidney Disease, Malnutrition-Inflammation Score, Subjective Global Assessment, Hemodialysis, Egg albumin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Medico Lic Adolfo Lopez MateOther government
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egg albumin-based protein supplement | Experimental | Dietary Supplement: Egg albumin-based protein supplementPowder form, dosage 30 g daily, duration 6 months |
| Renal-specific oral supplement | Active comparator | Dietary Supplement: Renal-specific oral supplementLiquid form, dosage 237 ml (one can) daily, duration 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Kidney Disease in Hemodialysis
Key exclusion criteria (5 listed)
- Infection
- Liver insufficiency
- Cancer or neoplasia
- Acquired immunodeficiency syndrome
- Intestinal malabsorption syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Egg albumin-based protein supplementAlso: Pure ProEgg | Dietary supplement | Egg albumin-based protein supplement |
| Renal-specific oral supplementAlso: Enterex Renal | Dietary supplement | Renal-specific oral supplement |
Primary outcome
Change in Malnutrition-Inflammation Score
Time frame: Bimonthly, up to six months
Change in Subjective Global Assessment
Time frame: Bimonthly, up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Egg albumin-based protein supplement and Renal-specific oral supplement in people with Protein-Energy Malnutrition and Kidney Failure, Chronic, run by Centro Medico Lic Adolfo Lopez Mate at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Gonzalez-Toledo, MD (52(722)2760860 ext. 90457, rtoledo29@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Malnutrition-Inflammation Score (time frame: Bimonthly, up to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.