Study to Evaluate the Protective Effect of α-Keto Acid With Low-protein Diet on Renal Function in PD Patients

Not Applicable

Completed

• Conditions: Peritoneal Dialysis
• Interventions: Dietary Supplement: α-Keto Acid with low protein diet; Dietary Supplement: Normal protein diet

• Registration Number: NCT00734552
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This randomized, open-label, prospective study will evaluate the renal effective effect of compound α-Keto Acid plus low protein diet in PD Patients.

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2009-10
• Study Completion: 2010-05
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients on PD at least one month prior to study entry.
2. Subjects of either sex, more than 20 years old, the range of age is 20 to 75 year old.
3. Residual GFR ≥3 ml/min/1.73m2.
4. Residual urine volume ≥ 500 ml/24h.
5. No history of taking α-Keto Acid within 2 weeks.
6. Subjects who agree to participate in the study and sign the informed consent.

Exclusion Criteria

1. History of peritonitis or other infection within one month.
2. History of taking drug which may affect amino acid metabolism within one month.
3. Incapable of following study requirements to control diet.
4. With severe cardiovascular disease, chronic liver disease, dyscrasia, psychiatric disorder, alcohol or drug abuse.
5. Participation in another clinic trial within one month prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	α-Keto Acid with low protein diet	α-Keto Acid plus low protein diet
2	Normal protein diet	Normal protein diet

Primary Outcome Measures

Name	Time	Method
The longitudinal change in residual glomerular filtration rate (GFR),residual urine volume	Every 3 months

Secondary Outcome Measures

Name	Time	Method
Peritoneal membrane transport characteristics,cardiovascular events,nutritional status,hospitalization, peritonitis episodes, any adverse drug effects.	Every 3 months

Trial Locations

Locations (1)

The 1st Affiliated Hospital, Sun Yet-sen University; 🇨🇳 GuangZhou, Guangdong, China