NCT03806998

Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure

Effects of a Ketoacid Supplementation on Urinary Urea Nitrogen Excretion in Patients With Stage III to IV Renal Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen

Detailed description

Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketoacids	Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
DIETARY_SUPPLEMENT	Placebo	Provision of placebo capsules similar to active supplement

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2019-01-16
• Last updated: 2019-01-16

Locations

1 site across 1 country: Chile