Status:
RECRUITING
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Lead Sponsor:
NIN Institute
Collaborating Sponsors:
Hospital Civil de Guadalajara
Conditions:
Chronic Kidney Diseases
Protein-Energy Malnutrition
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidit...
Detailed Description
Epidemiological studies have reported that between 30 and 50% of patients with kidney disease show signs of malnutrition and that specifically in patient with CKD in stages 4-5 without replacement the...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Patients with diabetic kidney with eGFR \<60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively)
- Patients with protein energy expenditure (defined by serum albumin \< 3.8 g/dl)
- Patients with protein energy expenditure (defined by 24-hour recall less than a dietary protein intake \<0.6 g/kg/d or have a consumption \<25 kcal/kg/d
- Patients who can read and write (or primary caregiver)
- Domicile within the metropolitan area
Exclusion
- Previous hospitalizations in the last month
- Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, cerebrovascular syndrome, malabsorption syndrome, or allergy to any ingredient in the nutritional supplement)
- Patients with actual consumption of food supplements and / or keto analogues.
- Elimination Criteria:
- Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.
- Failure to take the supplement \>10% (\>12 failed doses).
- Diagnosis of any comorbidity during the intervention period.
- Initiation of replacement therapy.
- Identification of adverse effects.
- Withdrawal of voluntary participation by the patient.
- Death.
Key Trial Info
Start Date :
July 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06576479
Start Date
July 10 2018
End Date
March 1 2025
Last Update
December 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280