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Sponsored by: |
Sun Yat-sen University |
---|---|
Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00734552 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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 |
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 |
---|---|
1: Active Comparator
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. |
2
Normal protein diet
|
Dietary Supplement: Normal protein diet
Diet contain protein 1.0-1.2 g/kg/d.
|
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.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Sun Yat-sen University ( Xueqing Yu/Director ) |
Study ID Numbers: | SYSU-KAPDRRF |
Study First Received: | August 13, 2008 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00734552 |
Health Authority: | China: State Food and Drug Administration |
Continuous Ambulatory Peritoneal Dialysis α-Keto Acid Low Protein Diet Residual Renal Function |