End-Stage Renal DiseaseNCT00687050
Peroral Supplemental Nutrition in End-stage Renal Disease With and Without HIV Comorbidity
A study testing peroral high-caloric supplemental nutrition and peroral supplemental nutrition in people with End-Stage Renal Disease, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- peroral high-caloric supplemental nutrition and peroral supplemental nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to May 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients on hemodialysis for more than 1 year,
- Group 1: HIV infection
Who cannot join
- patients on hemodialysis for less than 1 year,
- Group 2 and 3: HIV infection
- no pre-/post dialysis weight differences of > 3 kg after long HD free interval over last 10 HD sessions.
- no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons.
- pregnancy
- for women: no use of oral contraceptives or other at least equally effective contraception in women with childbearing potential
- known neoplastic disease other than skin tumors (except melanoma)
- mental disease or retardation with impaired judgement power
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hospital of the Goethe University Frankfurt am Main
Frankfurt am Main, 60590
About this study
Official title: MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity
End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition. The nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV patients. This pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.
Read the detailed description
In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes, malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is unclear.
Hypothesis to be tested:
Daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.
- Conditions
- End-Stage Renal Disease
- Being tested
- peroral high-caloric supplemental nutrition, peroral supplemental nutrition
- Keywords
- end-stage renal disease, chronic kidney disease
- Medical subject headings
- 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.
peroral high-caloric supplemental nutritionDietary supplement
Also called Renilon 7.5 by Pfrimmer Nutricia
HIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet
peroral supplemental nutritionDietary supplement
Also called Renilon 7.5 by Pfrimmer-Nutricia
Chronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | HIV-positive hemodialysis patients (as a high risk group for cachexia) will be given daily drinks of Renilon 7.5 (125 ml, 2 kcal/ml) as peroral supplemental nutrition on top to their recommended high-protein, high-caloric diet. Receives: Dietary Supplement: peroral high-caloric supplemental nutrition |
| 2 | No intervention | Chronic hemodialysis patients randomized to no peroral supplemental nutrition |
| 3 | Active comparator | Chronic hemodialysis patients randomized to peroral supplemental nutrition. Receives: Dietary Supplement: peroral supplemental nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area of triceps m. in mid-humerus position (MRT)
Measured: 6 months
Secondary outcomes (1)
plasma albumin < 3.6 mg/dl
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionMay 2010
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 End-Stage Renal DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfrimmer Nutricia GmbH, Erlangen , Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687050
- Sponsor's protocol ID
- Goethe-Uni-FFM-328-07
- Status last verified
- May 2010
- First submitted
- 27 May 2008
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Zilles M, Betz C, Jung O, Gauer S, Hammerstingl R, Wachtershauser A, Vogl TJ, Geiger H, Asbe-Vollkopf A, Pliquett RU. How to Prevent Renal Cachexia? A Clinical Randomized Pilot Study Testing Oral Supplemental Nutrition in Hemodialysis Patients With and Without Human Immunodeficiency Virus Infection. J Ren Nutr. 2018 Jan;28(1):37-44. doi: 10.1053/j.jrn.2017.07.003. Epub 2017 Nov 14.
PubMed 29146139
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRT-based Pilot Study to Evaluate Peroral Supplemental Nutrition for Prevention of Cachexia in End-stage Renal Disease With and Without HIV Comorbidity
- ClinicalTrials.gov ID
- NCT00687050
- Acronym / sponsor ID
- Goethe-Uni-FFM-328-07
- Conditions
- End-Stage Renal Disease
- Keywords
- end-stage renal disease, chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Pfrimmer Nutricia GmbH, Erlangen , Germany
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 May 2008 (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.
End-stage renal disease is often accompanied by malnutrition due to less appetite, metabolic changes or both. Human immunodeficiency virus-infection may exacerbate the state of malnutrition. In a pilot study, we recruit both HIV invected and non-infected patients on hemodialysis. Non-HIV patients will be randomized to peroral supplemental nutrition or no peroral supplemental nutrition. All HIV patients will receive peroral supplemental nutrition. The nutritional state will be determined in magnet resonance tomography at the start and at the end of the study (muscle diameter of triceps m.) and with laboratory parameters (plasma albumin and others). The hypothesis is that supplemental peroral nutrition (a total 250 kcal per day) will stop loss of muscle mass in end-stage renal disease patients (compared to their counterparts without supplemental peroral nutrition) as well as in the high risk group of HIV patients. This pilot study may lead to larger randomized clinical trials and, may affect dietary recommendations.
Detailed description
In end-stage renal disease (ESRD), cachexia is a common finding. Metabolic changes, malnutrition, or both appear to be the underlying problems. In fact, lean body mass per body weight better predicts prognosis than creatinin based models (NDT, 2004.19:1182). In addition, comorbidity such as HIV infection may exacerbate cachexia found in ESRD. Whether or not daily supplemental, high-caloric nutrition in ESRD corrects a catabolic state in ESRD is unclear.
Hypothesis to be tested:
Daily supplemental high-caloric nutrition beneficially affects cytokine stimulation (TNF alpha, IL 1beta, IL 6, CrP) and nutritional state (cross sectional area of triceps m. in mid-humerus position (MRT), plasma albumin) in in HIV-positive hemodialysis patients and in chronic hemodialysis patients compared to chronic hemodialysis patients without supplemental nutrition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: peroral high-caloric supplemental nutritionHIV-positive hemodialysis patients (as a high risk group for cachexia) will be given daily drinks of Renilon 7.5 (125 ml, 2 kcal/ml) as peroral supplemental nutrition on top to their recommended high-protein, high-caloric diet. |
| 2 | No intervention | –Chronic hemodialysis patients randomized to no peroral supplemental nutrition |
| 3 | Active comparator | Dietary Supplement: peroral supplemental nutritionChronic hemodialysis patients randomized to peroral supplemental nutrition. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients on hemodialysis for more than 1 year,
- Group 1: HIV infection
Key exclusion criteria (8 listed)
- patients on hemodialysis for less than 1 year,
- Group 2 and 3: HIV infection
- no pre-/post dialysis weight differences of > 3 kg after long HD free interval over last 10 HD sessions.
- no current high-caloric nutrition supplements or planned high-caloric supplements for clinical reasons.
- pregnancy
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 |
|---|---|---|
| peroral high-caloric supplemental nutritionAlso: Renilon 7.5 by Pfrimmer NutriciaHIV-positive hemodialysis patients will be given daily supplemental nutrition (125 ml, 2 kcal/ml) on top of recommended high-protein, high-caloric regular diet | Dietary supplement | 1 |
| peroral supplemental nutritionAlso: Renilon 7.5 by Pfrimmer-NutriciaChronic hemodialysis patients will be given daily peroral supplemental nutrition (125 ml/d, 2 kcal/ml) on top of their recommended high-protein, high caloric diet | Dietary supplement | 3 |
Primary outcome
Cross sectional area of triceps m. in mid-humerus position (MRT)
Time frame: 6 months
1 secondary outcome
plasma albumin < 3.6 mg/dl
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
- Derived from this study: PubMed 29146139Zilles M, Betz C, Jung O, Gauer S, Hammerstingl R, Wachtershauser A, Vogl TJ, Geiger H, Asbe-Vollkopf A, Pliquett RU. How to Prevent Renal Cachexia? A Clinical Randomized Pilot Study Testing Oral Supplemental Nutrition in Hemodialysis Patients With and Without Human Immunodeficiency Virus Infection. J Ren Nutr. 2018 Jan;28(1):37-44. doi: 10.1053/j.jrn.2017.07.003. Epub 2017 Nov 14.
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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 peroral high-caloric supplemental nutrition and peroral supplemental nutrition in people with End-Stage Renal Disease, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 May 2010. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cross sectional area of triceps m. in mid-humerus position (MRT) (time frame: 6 months). 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 NCT00687050, 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 26 May 2010.