Fact CheckerSign in

NCT06576479Recruiting

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

Validation of the Therapeutic Effect and Safety of a Specialized Oral Supplement on the Nutritional Status and Quality of Life in Patients with Chronic Kidney Disease Without Replacement Therapy: (Grade G3a, G3b, G4 and G5)

Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
19 Aug 2024
Start date
10 Jul 2018
Primary completion date
Feb 2025
Lead sponsor
NIN Institute
NCT number
NCT06576479

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 10 Jul 2018 to the primary completion date, Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous hospitalizations in the last month
  • Initiation of replacement therapy.

Other illness

  • 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)
  • 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).

Other

  • Patients with actual consumption of food supplements and / or keto analogues.
    • Elimination Criteria:
  • Diagnosis of any comorbidity during the intervention period.
  • Identification of adverse effects.
  • Withdrawal of voluntary participation by the patient.
  • Death.

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Civil Fray Antonio Alcalde
Coordinator of this site? Confirm its status
GuadalajaraMexicoRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.