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Supplemented Low Protein Diet and Progression of CKD

NCT03818568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2021-08-12

No results posted yet for this study

Summary

Investigators intend to analyze diets restricted in protein and supplemented with ketoanalogues of essential amino acids, to slow the progress of renal damage and improve nutritional status in diabetic patients over 60 years with stage 4 chronic kidney disease.

Evey 2 months, evaluations were performed of renal function (creatinine clearance, serum cysteine, proteinuria) and nutritional status (subjective global evaluation,dominant had pressure strength, body composition by bioelectric impedance, serum transferrin, serum prealbumin and serum aminogram) for a follow-up period of 2 years.

Conditions

  • Stage 4 Chronic Kidney Disease

Interventions

DIETARY_SUPPLEMENT

ketoanalogues of essential amino acids

Patients will receive conventional treatment according to the institution's clinical guidelines, with moderate restriction of proteins 0.6 g protein/kg/day, as recommended to slow renal damage progression), plus ketoanalogues in the established dosage (1 tablet/5 kg weight divided into 3 doses per day).

Sponsors & Collaborators

  • Fresenius Kabi

    collaborator INDUSTRY

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Ramon Paniagua, MD, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-01-31
Completion
2021-02-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818568 on ClinicalTrials.gov