Malnutrition Clinical Trial
Official title:
Assess Effect of Oral Nutritional Supplementation on Oxidative Stress Levels in Protein-energy Wasting Patients With Continuous Ambulatory Peritoneal Dialysis
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT03268902 -
Early Life Interventions for Childhood Growth and Development In Tanzania
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
| Completed |
NCT04608656 -
Livestock for Health Project
|
N/A | |
| Completed |
NCT06009198 -
Nutritional, and WASH Related Education Intervention to Address Malnutrition of Early Adolescents in Pakistan
|
N/A | |
| Recruiting |
NCT05417672 -
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy
|
||
| Recruiting |
NCT05257980 -
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial
|
N/A | |
| Completed |
NCT05015647 -
Low Protein Diet in CKD Patients at Risk of Malnutrition
|
N/A | |
| Completed |
NCT03628196 -
A Nutrition-Focused QIP in Outpatient Clinics
|
||
| Enrolling by invitation |
NCT04675229 -
Extending the Validation of SCREEN to Persons Living With Dementia or in Retirement Homes
|
||
| Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
| Not yet recruiting |
NCT06047054 -
Incidence Rate and Risk Factors of Malnutrition in ICU
|
||
| Not yet recruiting |
NCT05860556 -
Sustainable Eating Pattern to Limit Malnutrition in Older Adults
|
||
| Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 | |
| Not yet recruiting |
NCT04183075 -
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
|
N/A | |
| Not yet recruiting |
NCT03150927 -
Clinical Study of Novel Probiotic Microbial Composite™ to Treat Undernourished Young Children
|
N/A | |
| Recruiting |
NCT02833740 -
Comparing Performance of Simplified Mid-Upper Arm Circumference Devices ("Click-MUACs") to Detect Acute Malnutrition
|
N/A | |
| Recruiting |
NCT03408067 -
Evaluation of the Efficacy of Nutritional Risk Screening Tests, NRS 2002 and SGA, to Identifying Malnourished Patients
|
N/A | |
| Completed |
NCT02938247 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake
|
N/A | |
| Completed |
NCT02938234 -
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake
|
N/A |