Renal Insufficiency, ChronicUAUDIPENCT03236701
Egg White for Phosphorus Control in Haemodialysis Patients
A study testing Egg White replacement in people with Renal Insufficiency, Chronic and Dialysis, run by Federico II University at 1 site in Italy.
Trial summary
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Dialysis, Hyperphosphatemia
- What is being tested?
- Egg White replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2017to 15 Dec 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage
- stable dialysis dose and modality at least by 3 months
- hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months
- stable dietary intake at least by 3 months
- stable body weight at least by 3 months
- stable biochemical markers at least by 3 months
Who cannot join
- diabetes
- liver disease
- malignancy
- previous parathyroidectomy
- psychiatric diseases
- non-collaborative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins.
Read the detailed description
Hyperphosphatemia develops in the majority of patients with end-stage renal disease (ESRD). It is responsible for severe complications such as mineral bone disease, and has a role in worsening the cardiovascular mortality of dialyzed patients. Therefore, a close control of serum phosphorus remains a cornerstone in the clinical management of dialyzed patients to improve their long term prognosis. There are multiple sources of phosphorus in the diet that could be the target of such a dietary intervention but, because of important differences in bioavailability, they are not all equally relevant in influencing phosphatemia. Among them animal proteins that have a bioavailability of about 60% represent an important target for phosphate-lowering nutritional interventions. However, lowering the protein content of the diet in hemodialysis (HD) patients may be dangerous because it may increase the the risk of malnutrition hence worsening their prognosis. In the present study we intend to explore an alternative strategy to lower the intake of phosphate with animal proteins by replacing the meat or fish included in two meals a week with egg white that is reach of proteins but has virtually no phosphate.
- Conditions
- Renal Insufficiency, Chronic, Dialysis, Hyperphosphatemia
- Being tested
- Egg White replacement
- Keywords
- hyperphosphatemia, hemodialysis, dietary treatment, egg white, protein energy wasting
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg White replacementOther
Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | usual diet |
| Intervention | Experimental | egg white instead of meat or fish in two meals twice a week for three months Receives: Other: Egg White replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in serum phosphate levels
This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia
Measured: Phosphate level will be measured monthly for three months from the beginning of the study
Secondary outcomes (3)
Changes in body composition assessed by bioelectrical impedance analysis
Protein malnutrition causes a decrease in body cell mass. By bioelectrical impedance analysis (BIA) the changes in this parameter in the two experimental groups will be evaluated at one, two and three months from the beginning of the study.
Measured: BIA will be performed monthly for three months from the beginning of the study
Changes in serum albumin concentration
Protein malnutrition causes a decrease in serum albumin concentration that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Measured: Serum albumin will be measured monthly for three months from the beginning of the study
Changes in hemoglobin levels
Protein malnutrition causes a decrease in hemoglobin levels that will be, therefore, monitored, at one, two and three months from the beginning of the study.
Measured: hemoglobin level will be measured monthly for three months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start15 Jun 2017
- Primary completionNov 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruna Guida, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236701
- Sponsor's protocol ID
- 76/17
- Acronym
- UAUDIPE
- Status last verified
- Sep 2017
- First submitted
- 24 Jul 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guida B, Parolisi S, Coco M, Ruoppo T, Veccia R, di Maro M, Trio R, Memoli A, Cataldi M. The impact of a nutritional intervention based on egg white for phosphorus control in hemodialyis patients. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):45-50. doi: 10.1016/j.numecd.2018.09.010. Epub 2018 Sep 28.
PubMed 30459073
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Nutritional Intervention Based on Egg White for Phosphorus Control in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT03236701
- Acronym / sponsor ID
- UAUDIPE / 76/17
- Conditions
- Renal Insufficiency, Chronic, Dialysis, Hyperphosphatemia
- Keywords
- hyperphosphatemia, hemodialysis, dietary treatment, egg white, protein energy wasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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.
To evaluate the effect on phosphatemia in hemodialysis patients of replacing the meat or fish included in two meals a week with an amount of egg white containing the same quantity of proteins.
Detailed description
Hyperphosphatemia develops in the majority of patients with end-stage renal disease (ESRD). It is responsible for severe complications such as mineral bone disease, and has a role in worsening the cardiovascular mortality of dialyzed patients. Therefore, a close control of serum phosphorus remains a cornerstone in the clinical management of dialyzed patients to improve their long term prognosis. There are multiple sources of phosphorus in the diet that could be the target of such a dietary intervention but, because of important differences in bioavailability, they are not all equally relevant in influencing phosphatemia. Among them animal proteins that have a bioavailability of about 60% represent an important target for phosphate-lowering nutritional interventions. However, lowering the protein content of the diet in hemodialysis (HD) patients may be dangerous because it may increase the the risk of malnutrition hence worsening their prognosis. In the present study we intend to explore an alternative strategy to lower the intake of phosphate with animal proteins by replacing the meat or fish included in two meals a week with egg white that is reach of proteins but has virtually no phosphate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –usual diet |
| Intervention | Experimental | Other: Egg White replacementegg white instead of meat or fish in two meals twice a week for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- thrice weekly 4 h standard bicarbonate HD treatment with an at least 6-month vintage
- stable dialysis dose and modality at least by 3 months
- hyperphosphataemia (serum phosphate ≥5.0 mg/dl) at least by 3 months
- stable dietary intake at least by 3 months
- stable body weight at least by 3 months
Key exclusion criteria (6 listed)
- diabetes
- liver disease
- malignancy
- previous parathyroidectomy
- psychiatric diseases
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 White replacementNutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white. | Other | Intervention |
Primary outcome
Decrease in serum phosphate levels
Time frame: Phosphate level will be measured monthly for three months from the beginning of the study
This is the primary outcome because of the link between cardiovascular mortality and hyperphosphatemia
3 secondary outcomes
Changes in body composition assessed by bioelectrical impedance analysis
Time frame: BIA will be performed monthly for three months from the beginning of the study
Changes in serum albumin concentration
Time frame: Serum albumin will be measured monthly for three months from the beginning of the study
Changes in hemoglobin levels
Time frame: hemoglobin level will be measured monthly for three months from the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 30459073Guida B, Parolisi S, Coco M, Ruoppo T, Veccia R, di Maro M, Trio R, Memoli A, Cataldi M. The impact of a nutritional intervention based on egg white for phosphorus control in hemodialyis patients. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):45-50. doi: 10.1016/j.numecd.2018.09.010. Epub 2018 Sep 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg White replacement in people with Renal Insufficiency, Chronic and Dialysis, run by Federico II University at 1 site in Italy.
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 6 inclusion and 6 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 15 Sep 2017. 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 Italy. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in serum phosphate levels (time frame: Phosphate level will be measured monthly for three months from the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03236701, which also lists 1 linked publication.
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 15 Sep 2017.