Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03475017 |
| Other study ID # |
Denisemafra4 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 22, 2018 |
| Est. completion date |
December 30, 2021 |
Study information
| Verified date |
December 2023 |
| Source |
Universidade Federal Fluminense |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Many studies have been conducted to identify therapeutic strategies to modulate inflammation
and oxidative stress, complications that contribute to the increased morbidity and
cardiovascular mortality in patients with chronic kidney disease (CKD). Among several
non-pharmacological strategies, the use of bioactive compounds has emerged as a potential
approach to reduce these complications in CKD patients. In this context, turmeric/curcumin
may have positive consequences in terms of cardiovascular and nephroprotection because of its
antibacterial, antiviral, anti-inflammatory and anti-oxidative effects. The aim of this study
is the role of curcumin as a nutritional strategy to reduce cardiovascular risk factors as
inflammation and oxidative stress in CKD patients.
Description:
This is a longitudinal study of the type randomized crossover, double-blind,
placebo-controlled, washout period. We selected 30 patients with CKD in hemodialysis at
Clínica Renalcor / RJ (second sample calculation, considering p = 0.05 and test power of
80%). Eligible patients of both genders, previously evaluated and authorized by the medical
staff of the clinic, were invited to participate in the research.
The research was carried out after signing the free and informed consent form, according to
the standards of the local Research Ethics Committees and required by Resolution 466 of
December 12, 2012 (Conselho Nacional de Saúde), based on the guidelines of the Declaration of
Helsinki and of the World Medical Association on human research. This project was approved by
the Ethics Committee of the Faculty of Medicine / UFF, number: 2.346.933. It is registered
with ClinicalTrials.gov under the number NCT 03475017.
Inclusion and exclusion criteria:
Patients with stage 5 CKD (GFR <15 mL / min) on hemodialysis for more than 6 months, aged at
least 18 years, and who had arteriovenous fistula (AVF) as vascular access were included in
the study. Patients who were pregnant, smokers, antibiotics in the last 3 months, antioxidant
supplements and habitual turmeric and / or turmeric intake, besides those with autoimmune and
infectious diseases, cancer, hepatic diseases and AIDS were not included in the study.
The food intake was evaluated at the beginning and at the end of the intervention through the
24-h food recall technique. The analysis of total energy intake (kcal/kg), carbohydrates (%),
lipids (%), protein (g/kg), phosphorus (mg) and potassium (mg) were estimated using NutWin®
software.
Assessment of nutritional status Patients had their body weight (kg), height (m), arm
circumference (cm), waist circumference (WC) (cm) and skinfold measurements (mm) (biceps,
triceps, subscapular, and suprailiac) measured with the aid of calibrated balance,
stadiometer, tape measure and Lange Skinfold Caliper type adipometer (Cambridge Scientific
Industries Inc.) before and after intervention. Body mass index (BMI) was calculated from dry
body weight (kg) divided by squared height (m). Arm muscle area and body fat percentage were
calculated. All measurements were performed after the dialysis session by a trained staff
member.
Blood collection and biochemical analyzes Samples were collected in the morning after a 12-h
fasting before dialysis and immediately after arteriovenous fistula puncture in Vacutainer®
tubes containing ethylenediamine tetraacetic acid (EDTA) with anticoagulant (1.0 mg/mL).
After collection, an aliquot was used for the analysis with whole blood and another one was
centrifuged at 2500 rpm for 10 min at 4 C to obtain the plasma, which was distributed in 1.5
mL polypropylene eppendorfs tubes, identified and aliquoted for each analysis and stored at
80 C for further analysis. The whole blood was used to obtain the peripheral blood
mononuclear cells (PBMC).
Real time PCR analysis Nrf2, NF-kB mRNA expression were evaluated from PBMC using
quantitative real-time polymerase chain reaction (qPCR). TaqMan Gene Expression (Thermo
Fisher®) assays for the detection of Nrf2 (Hs00975961_g1), NF-kB (Hs00765730_m1), and GAPDH
(Hs02758991_g1) control mRNA expression were used. The Prism 7500 Sequence Detection System
ABI (Applied Biosystems®) and the standard cyclic conditions were used for PCR amplification.
NRf2, NF-kB mRNA expression were normalized against GAPDH, and the level of expressionwas
calculated using the DDCT (delta delta threshold cycle) method.
Biochemical parameters Relevant information such as the etiology of CKD and age were
collected from patients' records. Routine biochemical exams corresponding to collection
dates, such as urea, Kt/v, hemoglobin and albumin, serum phosphorus, potassium, parathyroid
hormone, glucose, and glycated hemoglobin were also obtained from routine medical records.
Serum levels of high sensitivity C-reactive protein (hsCRP), total cholesterol,
triglycerides, c-HDL were determined using BioClin® kits using the biochemical analyzer
Bioclin BS-120 Chemistry Analyze. LDL was calculated using the Friedewald equation,
considering triglyceride values below 400 mg/dL: LDL Cholesterol ¼ (Total Cholesterol) - (HDL
Cholesterol) - (Triglycerides)/5.
