Oxidative Stress
Conditions
Interventions
This is a 12-week untreated controlled clinical trial with a sample of 150 chronic kidney disease (CKD) patients seen at the Nephrology Outpatient Clinic at Londrina State University Hospital (HC-UEL)
Drug
V03.175.250
Sponsors
Universidade Estadual de Londrina
Universidade Estadual de Londrina
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients of both sexes; aged over 18 years in full cognitive condition; with no comorbidities that prevent participation in this study and who have glomerular filtration rate (GFR) according to those described according to the National Kidney Foundation (2015); to determine the stage of CKD: 3a - GFR of 59-44 mL / min / 1.73 m2; 3b - GFR of 44-33 mL / min / 1.73 m2; 4 - GFR of 29-15 mL / min / 1.73 m2
Exclusion criteria
Exclusion criteria: Patients with chronic viral infection; autoimmune disease and malignancy; treatment with antioxidants or anti-inflammatory drugs will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in the estimated glomerular filtration rate after 3 months of folic acid intervention in patients with chronic kidney disease, estimated by the Modification of Diet in Renal Disease (MDRD) study equation based on serum creatinine level, age, gender and ethnicity of the patient.;To evaluate creatinine levels. Through automated analyzes performed on the Dimension® device, RxL (Deerfield, IL, USA). Results expressed in mg/dL, from the observation of a variation of at least 5% in the pre and post-intervention measurements.;To evaluate homocysteine levels. Through automated methodology on the Architect i2000SR device (Abbott, IL, USA). Results expressed in mmol/L, from the observation of a variation of at least 5% in the pre and post-intervention measurements;To evaluate folic acid levels. Through automated analyzes performed on the Dimension® device, RxL (Deerfield, IL, USA). Results expressed in mg / mL, from the observation of a variation of at least 5% in the pre and post-intervention measurements.;To evaluate antioxidant biomarkers such as the activity of the SOD enzyme in erythrocytes. Using the pyrogallol method described by Marklund et al. (1974), which is based on the inhibition that this enzyme promotes in the auto-oxidation of pyrogallol in aqueous solution. The amount of SOD that will be able to inhibit 50% of pyrogallol oxidation will be defined as a unit of enzymatic activity. Results will be expressed in USOD / min / gHb.;To evaluate the activity of the catalase enzyme. using the technique described by Aebi (1984), analyzing the measurement of the decay in the concentration of H2O2 and the generation of oxygen. Results will be expressed in ABS / min / gHb, from the observation of a variation of at least 5% in the pre and post-intervention measurements.;To evaluate the activity of Glutathione peroxidase (Gpx). Using the method described by Sies et al. (1979). The method for determining the activity of this enzyme is ba | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactDécio Barbosa
Universidade Estadual de Londrina
Outcome results
None listed