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

NCT ID: NCT01999023

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Observational group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Dietary supplement

Low protein formula formula (28.5 g) twice a day

Group Type EXPERIMENTAL

Low protein formula group

Intervention Type DIETARY_SUPPLEMENT

Low protein formula formula (28.5 g) twice a day

Interventions

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Low protein formula group

Low protein formula formula (28.5 g) twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Yi-Chia Huang, PhD

Role: CONTACT

Phone: +886424730022

Email: [email protected]

Facility Contacts

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Yi-Chia Huang, PhD

Role: primary

Other Identifiers

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SF13223

Identifier Type: -

Identifier Source: org_study_id