Chronic Kidney DiseaseNCT00633646
Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in Peritoneal Dialysis (PD) Patients
A study testing diets contained different levels of protein in people with Chronic Kidney Disease and Peritoneal Dialysis, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Peritoneal Dialysis
- What is being tested?
- diets contained different levels of protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Feb 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years
- stable peritoneal dialysis since at least 1 month
- with renal function
Who cannot join
- a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year
- overt infection within the last month
- poor compliance in previous dietary prescriptions or irregular check-ups
- persistent anorexia, vomiting or diarrhea within the last month
- a CRP of more than 30 mg/dL
- presence of wasting diseases such as cancer or tuberculosis
About this study
Official title: Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients
Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.
Read the detailed description
Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a decreased protein intake has been associated with a retardation of kidney function loss in non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual renal function(RRF), current therapy recommendations in dialysis are for a normal protein intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent protein-energy wasting (PEW).
We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF also in dialysis patients and conducted two prospective, randomized trials involving a total of 94 peritoneal dialysis (PD) patients to test our hypothesis.
- Conditions
- Chronic Kidney Disease, Peritoneal Dialysis
- Being tested
- diets contained different levels of protein
- Keywords
- nitrogen balance, malnutrition, chronic kidney disease, diet, glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Chronic, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diets contained different levels of proteinDietary supplement
Also called LP, sLP, HP
diets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | low protein diet Receives: Dietary Supplement: diets contained different levels of protein |
| 2 | Active comparator | low protein diet with keto acids Receives: Dietary Supplement: diets contained different levels of protein |
| 3 | Active comparator | high protein diet Receives: Dietary Supplement: diets contained different levels of protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
nitrogen balance,residual renal function and nutritional status
Measured: 10 day and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Yao Qiang, MD, Ph.D, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633646
- Sponsor's protocol ID
- 05PJ14057(Shanghai, China)
- Status last verified
- Mar 2008
- First submitted
- 22 Feb 2008
- Last updated
- 28 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein-Restricted Diet on Nitrogen Balance and Residual Renal Function in PD Patients
- ClinicalTrials.gov ID
- NCT00633646
- Acronym / sponsor ID
- 05PJ14057(Shanghai, China)
- Conditions
- Chronic Kidney Disease, Peritoneal Dialysis
- Keywords
- nitrogen balance, malnutrition, chronic kidney disease, diet, glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Mar 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.
Current therapy recommendations suggest a low protein diet to preserve residual renal function (RRF) before the start of dialysis, but a higher protein intake during dialysis to prevent protein-energy wasting (PEW). We conducted a randomized trial to test whether low protein intake also during treatment with peritoneal dialysis (PD) would be safe and associated with a preserved RRF.
Detailed description
Dietary protein is the major source of nitrogen excreted as urea by the kidney, and a decreased protein intake has been associated with a retardation of kidney function loss in non-dialysis chronic kidney disease (CKD) patients. While a low protein diet is recommended to end-stage renal disease (ESRD) patients before the start of dialysis to preserve residual renal function(RRF), current therapy recommendations in dialysis are for a normal protein intake of no less than 1.2 g of protein/kg ideal body weight (IBW)/day to prevent protein-energy wasting (PEW).
We hypothesized that a lower protein intake would be safe and able to slow the loss of RRF also in dialysis patients and conducted two prospective, randomized trials involving a total of 94 peritoneal dialysis (PD) patients to test our hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: diets contained different levels of proteinlow protein diet |
| 2 | Active comparator | Dietary Supplement: diets contained different levels of proteinlow protein diet with keto acids |
| 3 | Active comparator | Dietary Supplement: diets contained different levels of proteinhigh protein diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-80 years
- stable peritoneal dialysis since at least 1 month
- with renal function
Key exclusion criteria (6 listed)
- a high probability (assessed by the recruiting physician) of receiving a kidney transplant within one year
- overt infection within the last month
- poor compliance in previous dietary prescriptions or irregular check-ups
- persistent anorexia, vomiting or diarrhea within the last month
- a CRP of more than 30 mg/dL
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 |
|---|---|---|
| diets contained different levels of proteinAlso: LP, sLP, HPdiets contain protein in the range of 0.6-0.8 or 1.0-1.2 g/kg/d | Dietary supplement | 1, 2, 3 |
Primary outcome
nitrogen balance,residual renal function and nutritional status
Time frame: 10 day and 1 year
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 28 Apr 2008.
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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.
Yao Qiang, MD, Ph.D principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing diets contained different levels of protein in people with Chronic Kidney Disease and Peritoneal Dialysis, run by Shanghai Jiao Tong University School of Medicine.
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 3 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: finished, as of the sponsor's last update on 28 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
nitrogen balance,residual renal function and nutritional status (time frame: 10 day and 1 year). 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 28 Apr 2008.