Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis… (NCT06576479) | Clinical Trial Compass
RecruitingNot Applicable
Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Mexico50 participantsStarted 2018-07-10
Plain-language 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 morbidity and mortality.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.