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

Sun Yat-sen University

Status: Completed

Conditions: Peritoneal Dialysis

Treatments: Dietary Supplement: α-Keto Acid with low protein diet; Dietary Supplement: Normal protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT00734552

SYSU-KAPDRRF

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

α-Keto Acid plus low protein diet

Treatment:

Dietary Supplement: α-Keto Acid with low protein diet

2

Other group

Description:

Normal protein diet

Treatment:

Dietary Supplement: Normal protein diet