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Clinical Trials in Mexico / NCT06576479
Recruiting Not applicable

Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD

NCT06576479 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2018-07-10
Last updated
2024-12-18

Condition(s) studied

Chronic Kidney DiseasesProtein-Energy Malnutrition

Investigational drug(s) / intervention(s)

Nutritious ShakeNutritional counseling

Nutritious Shake: Powder 70 g/d diluted in 237 ml natural water

Nutritional counseling: Specialized nutritional recommendations for CKD

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Civil Fray Antonio Alcalde Guadalajara Jalisco Recruiting

More NIN Institute trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06576479 on ClinicalTrials.gov ↗ ← All trials in Mexico