Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis
Primary Purpose
Oxidative Stress, Protein-Energy Wasting, Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral nutritional supplementation for kidney disease
Sponsored by
About this trial
This is an interventional treatment trial for Oxidative Stress
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of protein-energy wasting evaluated by 7-point Subjective Global Assessment (moderate/severe), and Malnutrition-inflammation Score (a score ≥ 6).
- Male and female patients
- Age ≥ 18 and <60 years
- Receive continuous ambulatory peritoneal dialysis with at least 3 months of initiation of renal replacement therapy
- Patients without clinical or biochemical evidence of any infectious process (peritonitis, urosepsis, endocarditis, soft tissue infection, pneumonia, etc) or inflammatory systemic disease (systemic lupus erythematosus, vasculitis, connective tissue disease)
- Written informed consent
Exclusion Criteria:
- Supplementation with exogenous antioxidants 2 months prior
- Smoking less than 1 year
- Intermittent peritoneal dialysis or automated peritoneal dialysis
- PD catheter dysfunction
- Known allergy or intolerance to oral nutritional supplement for renal disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Oral nutritional supplementation
Arm Description
Nutritional counselling by individualized nutritional plan for 8 weeks.
Nutritional counselling by individualized nutritional plan plus oral nutritional supplementation for renal disease (237 mls per day) for 8 weeks.
Outcomes
Primary Outcome Measures
Change in oxidative stress levels, oxidants (products of Lipoperoxidation, 8-IP, NO), antioxidants (SOD, catalase, GPx, TAC), and oxidative DNA damage (8-OHdG, hOGG1).
As measured by the of OS markers, 10 mL of blood samples will be taken prior to nutritional evaluation, 5 mL with 0.1% of ethylenediaminetetraacetic (EDTA) tube and other 5 mL in dry tube. The blood will be centrifuged at 10,000 rpm for 10 min at room temperature; supernatants were stored in aliquots at -80°C until its final processing.
Secondary Outcome Measures
Change protein-energy wasting and dietary intake
Description: As measured by 7-point Subjective Global Assesment (SGA), SGA of 1-2 for severe PEW, 3-5 for mild-moderate protein energy wasting will be considered as presence of protein-energy wasting and malnutrition inflammation score (MIS) a score ≥ 6 will be considered as the presence of protein-energy wasting.
Full Information
NCT ID
NCT04628117
First Posted
October 28, 2020
Last Updated
November 8, 2020
Sponsor
Hospital Civil Juan I. Menchaca
1. Study Identification
Unique Protocol Identification Number
NCT04628117
Brief Title
Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis
Official Title
Assess Effect of Oral Nutritional Supplementation on Oxidative Stress Levels in Protein-energy Wasting Patients With Continuous Ambulatory Peritoneal Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2021 (Anticipated)
Primary Completion Date
May 28, 2022 (Anticipated)
Study Completion Date
March 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil Juan I. Menchaca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
End-stage kidney disease (ESKD) represents a serious public health problem in Mexico. Data from the United States Renal Data System (USRDS) have reported that the region of Jalisco (Mexico) is one of the places with the highest incidence rate of treated ESKD and use of peritoneal dialysis (PD). In patients with ESKD, oxidative stress (OS) has been recognized as a potential source of morbidity and mortality, since it is involved in the pathogenesis of atherosclerosis and other complications of ESRD. This can induce damage to DNA (nucleic acid), proteins, carbohydrates, and lipids.
Another common complication in ESKD patients receiving PD is protein-energy wasting (PEW), which is characterized by the decline in the body stores of protein and energy fuels (that is, body protein and fat masses) due to the multiple nutritional and catabolic alterations that occur in this condition. Diverse factors can affect the nutritional and metabolic status of patients with PD, for which they require interventions to reverse protein and energy depletion. Nutritional counseling can be a useful tool in PD patients in order to improve compliance with nutritional recommendations. The strategies more used for PEW include oral nutritional supplementation. Therefore, the purpose of this study is assess the effect of oral nutritional supplementation on OS in PEW patients with PD.
Detailed Description
The detection of patients is carried out in the Nephrology Service of the Hospital Civil de Guadalajara Dr. Juan I. Menchaca where the selection and exclusion criteria are evaluated.
The probabilistic group assignment is carried out using a sealed and opaque envelope.
Control group: only nutritional counselling for 8 weeks. Intervention group: nutritional counselling plus 237 mls per day of oral nutritional supplement for kidney disease.
Initial evaluation includes, anthropometric parameters and dietary intake. Demographic characteristics and OS levels, such as oxidants, antioxidants and oxidative DNA damage.
All nutritional counselling, dietary intake, medical nutrition theraphy (oral nutritional supplementation), assessment of OS levels, and anthropometric parameters will perform at 0, 4 and 8 weeks of follow up. Protein-energy wasting assessment only in the 0 and 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Protein-Energy Wasting, Malnutrition, Protein-Energy Malnutrition, Oral Nutritional Supplements, Peritoneal Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial with two-parallel-group in stable continuous ambulatory peritoneal dialysis patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Nutritional counselling by individualized nutritional plan for 8 weeks.
Arm Title
Oral nutritional supplementation
Arm Type
Experimental
Arm Description
Nutritional counselling by individualized nutritional plan plus oral nutritional supplementation for renal disease (237 mls per day) for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral nutritional supplementation for kidney disease
Intervention Description
237 mls per day for 8 weeks.
Primary Outcome Measure Information:
Title
Change in oxidative stress levels, oxidants (products of Lipoperoxidation, 8-IP, NO), antioxidants (SOD, catalase, GPx, TAC), and oxidative DNA damage (8-OHdG, hOGG1).
Description
As measured by the of OS markers, 10 mL of blood samples will be taken prior to nutritional evaluation, 5 mL with 0.1% of ethylenediaminetetraacetic (EDTA) tube and other 5 mL in dry tube. The blood will be centrifuged at 10,000 rpm for 10 min at room temperature; supernatants were stored in aliquots at -80°C until its final processing.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change protein-energy wasting and dietary intake
Description
Description: As measured by 7-point Subjective Global Assesment (SGA), SGA of 1-2 for severe PEW, 3-5 for mild-moderate protein energy wasting will be considered as presence of protein-energy wasting and malnutrition inflammation score (MIS) a score ≥ 6 will be considered as the presence of protein-energy wasting.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of protein-energy wasting evaluated by 7-point Subjective Global Assessment (moderate/severe), and Malnutrition-inflammation Score (a score ≥ 6).
Male and female patients
Age ≥ 18 and <60 years
Receive continuous ambulatory peritoneal dialysis with at least 3 months of initiation of renal replacement therapy
Patients without clinical or biochemical evidence of any infectious process (peritonitis, urosepsis, endocarditis, soft tissue infection, pneumonia, etc) or inflammatory systemic disease (systemic lupus erythematosus, vasculitis, connective tissue disease)
Written informed consent
Exclusion Criteria:
Supplementation with exogenous antioxidants 2 months prior
Smoking less than 1 year
Intermittent peritoneal dialysis or automated peritoneal dialysis
PD catheter dysfunction
Known allergy or intolerance to oral nutritional supplement for renal disease
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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24058721
Citation
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Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis
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