Effects of Low Protein Formula on Renal Function, Oxidative Stress and Antioxidant Capacities in CKD Patients

Chronic Renal Disease Clinical Trial

Official title:

The Effects of Low Protein Formula on Renal Function, Oxidative Stress and Antioxidant Capacities in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01999023
• Other study ID #: SF13223
• Status: Not yet recruiting
• Phase: N/A
• First received: November 20, 2013
• Last updated: November 25, 2013
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Taichung Veterans General Hospital
• Contact: Yi-Chia Huang, PhD
• Phone: +886424730022
• Email: ych[@]csmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Chronic renal disease is now the tenth leading cause of mortality Taiwan. It is worth to study the effect of low protein formula on the retardation of failing renal function, decrease plasma homocysteine and oxidative stress and further increase antioxidant capacities in patients with chronic kidney disease. The purpose of this study is going to investigate the effects of protein formula on renal function, homocysteine , oxidative stress and antioxidant capacities in patients with chronic kidney disease. One hundred and twenty patients with end stage renal disease (stage 2~4) who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital, Taichung. Participant patients will be blinded and randomly assigned to either the placebo (n = 60) or low protein formula (n = 60) for 12 weeks. Data on demography, anthropometry and medical history will be collected, and fasting blood samples and 24 h urine samples will be obtained at week 0, 12 and 24 during intervention period. The levels of hematological, plasma and erythrocyte PLP, plasma pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum vitamin B-12, homocysteine, lipid peroxidation indicators, glutathione, total antioxidant capacity and antioxidant enzymatic will be measured. Twenty-four hour urine volume will be recorded and urine creatinine and urea nitrogen will be analyzed. Creatinine clearance rate will be measured. Hopefully, the results of this study could provide more pictures on beneficial effects of low protein formula on renal function, plasma homocysteine, oxidative stress and antioxidant capacities in patients with chronic kidney disease.

Description:

Chronic renal disease is now the tenth leading cause of mortality Taiwan. It is worth to study the effect of low protein formula on the retardation of failing renal function, decrease plasma homocysteine and oxidative stress and further increase antioxidant capacities in patients with chronic kidney disease. The purpose of this study is going to investigate the effects of protein formula on renal function, homocysteine , oxidative stress and antioxidant capacities in patients with chronic kidney disease. This protocol is designed as a hospital-based blinded randomized placebo-controlled intervention trial. One hundred and twenty patients with end stage renal disease who meet the inclusion criteria will be recruited from Taichung General Veterans Hospital, Taichung. Participant patients will be blinded and randomly assigned to either the placebo (n = 60) or low protein formula (n = 60) for 12 weeks. Data on demography, anthropometry and medical history will be collected, and fasting blood samples and 24 h urine samples will be obtained at week 0, 12 and 24 during intervention period. The levels of hematological (red blood cell, hemoglobin, albumin, creatinine, urea nitrogen, total cholesterol, triglyceride, high and low density lipoprotein), plasma and erythrocyte PLP, plasma pyridoxal and 4-pyridoxic acid, serum and erythrocyte folate, serum vitamin B-12, homocysteine, lipid peroxidation indicators (serum malondialdehyde and oxidized low density lipoprotein), glutathione, total antioxidant capacity and antioxidant enzymatic activities (superoxide dismutase, glutathione peroxidase, glutathione S-transferase, glutathione reductase) will be measured. Twenty-four hour urine volume will be recorded and urine creatinine and urea nitrogen will be analyzed. Creatinine clearance rate will be measured. Hopefully, the results of this study could provide more pictures on beneficial effects of low protein formula on renal function, plasma homocysteine, oxidative stress and antioxidant capacities in patients with chronic kidney disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1) Diagnosed as stage 2 ~ 3 chronic kidney disease

Exclusion Criteria:

1. clinical unstable (i.e., systolic blood pressure < 90 mmHg, mean arterial blood pressure < 65 mmHg, fatal arrhythmia or the requirement of vasopressor to maintain blood pressure) or unconscious at any point during the study.

2. chronic diseases (i.e. liver disease, gastrointestinal diseases, alcoholism, cancer); or 3) being in pregnant or lactation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Low protein formula group
Low protein formula formula (28.5 g) twice a day

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine clearance rate		6 months	No