Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Recruiting now · Not applicable
Conditions studied: Chronic Kidney Diseases, Protein-Energy Malnutrition
In brief
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 morbidity and mortality.
Key facts
- Study ID
- NCT06576479
- Run by
- NIN Institute
- People needed
- 50
- Starts
- 2018-07-10
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2024-12-18
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hospital Civil Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico (enrolling)
Full record on ClinicalTrials.gov
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