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
- Diseases
- Chronic kidney disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Civil Fray Antonio Alcalde Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.