Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04628117
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-10-28
Brief Title:
Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis
Sponsor:
Hospital Civil Juan I Menchaca
Organization:
Hospital Civil Juan I Menchaca
Study Overview
Official Title:
Assess Effect of Oral Nutritional Supplementation on Oxidative Stress Levels in Protein-energy Wasting Patients With Continuous Ambulatory Peritoneal Dialysis
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None