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Effects of Curcumin in Patients in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03475017
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Denise Mafra, Universidade Federal Fluminense

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Dietary Supplement: Active Comparator: Supplement A Dietary Supplement: Placebo Comparator: Supplement B Not Applicable

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.

Experimental Design

Patients who accepted to participate in the study and who were included in the inclusion and exclusion criteria were randomized into two groups:

  1. Turmeric Group: patients will receive juice containing 100 ml of orange juice, 12 grams of carrot and 2.5 grams of turmeric 95% curcumin 3 times a week for 12 weeks.
  2. Placebo group: patients will receive the same juice, however, without the addition of curcumin turmeric 95%, for the same period of time as the turmeric group.

The juices were prepared by the team responsible for the research project, and delivered to the patients after the end of the dialysis procedure. After the supplementation period, the 12-weeks washout was performed for subsequent crossover of the patients.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Effects of Curcumin Supplementation in Inflammation, Oxidative Stress and Intestinal Microbiota in Patients With Chronic Kidney Disease
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Supplement A
Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
 Dietary Supplement: Active Comparator: Supplement A
The patients will receive 3 capsules per day containing 500mg of curcumin and 5mg of piperine for 4 weeks
Other Name: Curcumin and piperine
Placebo Comparator: Supplement B
Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
 Dietary Supplement: Placebo Comparator: Supplement B
The patients will receive 3 capsules of placebo per day containing 500mg of maize starch for 4 weeks
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475017


Locations
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Brazil
Denise Mafra Recruiting
Rio de Janeiro, RJ, Brazil, 22260050
Contact: Denise Mafra, phd    21985683003    dmafra30@gmail.com   
Sponsors and Collaborators
Denise Mafra
More Information
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Responsible Party: Denise Mafra, Doctor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT03475017     History of Changes
Other Study ID Numbers: Denisemafra4
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Curcumin
Piperine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 Enzyme Inhibitors