Study to Evaluate the Protective Effect of α-Keto Acid With Low-Protein Diet (LPD) on Renal Function (RRF) in Peritoneal Dialysis (PD) Patients
Recruitment status was Recruiting
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Purpose
This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.
| Condition | Intervention |
|---|---|
|
Continuous Ambulatory Peritoneal Dialysis |
Dietary Supplement: α-Keto Acid with low protein diet Dietary Supplement: Normal protein diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Open-Label, Prospective Study to Evaluate the Protective Effect of α-Keto Acid With Low-Protein Diet on Residual Renal Function (RRF) in Peritoneal Dialysis Patients |
- The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
- Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
α-Keto Acid plus low protein diet
|
Dietary Supplement: α-Keto Acid with low protein diet
Compound α-Keto Acid: The daily dose of compound α-Keto Acid is 0.1/kg/d. The total daily dose will be divided into three times a day. Low Protein Diet: Diet contain protein 0.8g/kg/d. Other Name: Test Group
|
|
2
Normal protein diet
|
Dietary Supplement: Normal protein diet
Diet contain protein 1.0-1.2 g/kg/d.
Other Name: Control Group
|
Detailed Description:
Residual renal function (RRF) is associated with cardiovascular complication, nutritional status, incidence of peritonitis, and quality of life in peritoneal dialysis (PD) patients. Therefore, RRF is an important determinant of mortality and morbidity in PD patients.
Previous studies have suggested that dietary protein restriction supplemented with compound keto/amino acids may slow the loss of RRF in chronic kidney disease patients. However, there is very few reports to address the effect of compound keto/amino acid supplementation in RRF in PD patients.
The aim of this study is to evaluate the protective effect of compound α-Keto Acid plus low protein diet in RRF in PD Patients.This is a randomized, open-label, prospective study. 100 patients who meet Inclusion/Exclusion criteria will be randomized into α-Keto Acid group or control group at the ratio of 1:1. α-Keto Acid group will use compound α-Keto Acid plus low protein diet, while control group will use normal protein diet.Compound α-Keto Acid dosage is 0.1/kg/d daily. The effect of compound α-Keto Acid plus low protein diet in RRF will be evaluated after 1 year treatment.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients on PD at least one month prior to study entry.
- Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
- Residual GFR ≥3 ml/min/1.73m2.
- Residual urine volume ≥ 500 ml/24h.
- No history of taking α-Keto Acid within 2 weeks.
- Subjects who agree to participate in the study and sign the informed consent.
Exclusion Criteria:
- History of peritonitis or other infection within one month.
- History of taking drug which may affect amino acid metabolism within one month.
- Incapable of following study requirements to control diet.
- With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
- Participation in another clinic trial within one month prior to screening.
Contacts and Locations| Contact: Xueqing Yu, M.D.& Ph.D. | 8620-87766335 | yuxq@mail.sysu.edu.cn |
| Contact: Haiping Mao, M.D.& Ph.D. | 8620-87755766 ext 8143 | haipingmao@126.com |
| China, Guangdong | |
| The 1st Affiliated Hospital, Sun Yet-sen University | Recruiting |
| GuangZhou, Guangdong, China, 510080 | |
| Contact: Xueqing Yu, M.D. & Ph.D. 8620-87766335 yuxq@mail.sysu.edu.cn | |
| Contact: Haiping Mao, M.D. & Ph.D. 8620-87755766 ext 8143 haipingmao@126.com | |
| Principal Investigator: Xueqing Yu, M.D.& Ph.D. | |
| Principal Investigator: | Xueqing Yu, M.D. & Ph.D. | 1st Affiliated Hospital, Sun Yat-Sen University |
More Information
No publications provided
| Responsible Party: | Xueqing Yu/Director, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00734552 History of Changes |
| Other Study ID Numbers: | SYSU-KAPDRRF |
| Study First Received: | August 13, 2008 |
| Last Updated: | March 9, 2009 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Sun Yat-sen University:
|
Continuous Ambulatory Peritoneal Dialysis α-Keto Acid Low Protein Diet Residual Renal Function |
ClinicalTrials.gov processed this record on June 17, 2013