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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
Hospital Civil Juan I. Menchaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxidative Stress

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 28, 2020
    Last Updated
    November 8, 2020
    Sponsor
    Hospital Civil Juan I. Menchaca
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    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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