- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03475017
Effects of Curcumin in Patients in Chronic Kidney Disease
Effects of Curcumin Supplementation in Inflammation, Oxidative Stress and Intestinal Microbiota in Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 22260050
- Denise Mafra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinical diagnosis of Chronic Kidney Disease
- Hemodialysis patients for more than 6 months
- Aged 18 years or older
- Must be able to swallow tablets
Exclusion Criteria:
- Patients pregnant
- Smokers
- Using antibiotics in the last 3 months
- Using antioxidant supplements in the last 3 months
- Usual intake of turmeric
- Usual intake Autoimmune
- Clinical diagnosis of infectious diseases
- Clinical diagnosis of Cancer
- Clinical diagnosis of AIDS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Supplement A
Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
|
The patients will receive 3 capsules per day containing 500mg of curcumin and 5mg of piperine for 4 weeks
Other Names:
|
Placebo Comparator: Supplement B
Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
|
The patients will receive 3 capsules of placebo per day containing 500mg of maize starch for 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antioxidants and anti-inflammatory biomarkers
Time Frame: 4 weeks
|
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
|
4 weeks
|
Inflammatory biomarkers
Time Frame: 4 weeks
|
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Cytochrome P-450 Enzyme Inhibitors
- Curcumin
- Piperine
Other Study ID Numbers
- Denisemafra4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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