Chronic Renal DiseaseNCT01999023
Effects of Low Protein Formula on Renal Function, Oxidative Stress and Antioxidant Capacities in CKD Patients
A study testing Low protein formula group in people with Chronic Renal Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Low protein formula group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Diagnosed as stage 2 ~ 3 chronic kidney disease
Who cannot join
- 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.
- chronic diseases (i.e. liver disease, gastrointestinal diseases, alcoholism, cancer); or 3) being in pregnant or lactation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital
Taichung, 40705
Yi-Chia Huang, PhD, +886424730022 ext. 12198, ych@csmu.edu.tw
Cheng-Hsu Chen, MD, PhD
About this study
Official title: The Effects of Low Protein Formula on Renal Function, Oxidative Stress and Antioxidant Capacities in Patients With Chronic Kidney Disease
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.
Read the detailed 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.
- Conditions
- Chronic Renal Disease
- Being tested
- Low protein formula group
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low protein formula groupDietary supplement
Low protein formula formula (28.5 g) twice a day
| Study group | Role | What they receive |
|---|---|---|
| Observational group | No intervention | No intervention |
| Dietary supplement | Experimental | Low protein formula formula (28.5 g) twice a day Receives: Dietary Supplement: Low protein formula group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine clearance rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999023
- Sponsor's protocol ID
- SF13223
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Protein Formula on Renal Function, Oxidative Stress and Antioxidant Capacities in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01999023
- Acronym / sponsor ID
- SF13223
- Conditions
- Chronic Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational group | No intervention | –No intervention |
| Dietary supplement | Experimental | Dietary Supplement: Low protein formula groupLow protein formula formula (28.5 g) twice a day |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Diagnosed as stage 2 ~ 3 chronic kidney disease
Key exclusion criteria (2 listed)
- 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.
- chronic diseases (i.e. liver disease, gastrointestinal diseases, alcoholism, cancer); or 3) being in pregnant or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low protein formula groupLow protein formula formula (28.5 g) twice a day | Dietary supplement | Dietary supplement |
Primary outcome
Creatinine clearance rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low protein formula group in people with Chronic Renal Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Chia Huang, PhD (+886424730022 ext. 12198, ych@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine clearance rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.