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

NCT01999023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-12-03

No results posted yet for this study

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.

Conditions

  • Chronic Renal Disease

Interventions

DIETARY_SUPPLEMENT

Low protein formula group

Low protein formula formula (28.5 g) twice a day

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999023 on ClinicalTrials.gov