Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Curcumin in Patients in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03475017
Recruitment Status : Enrolling by invitation
First Posted : March 23, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Denise Mafra, Universidade Federal Fluminense

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 Phase 3

Layout table for study information
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: Supportive Care
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, 2018
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
Brazil
Denise Mafra
Niterói, Rio De Janeiro, Brazil
Sponsors and Collaborators
Denise Mafra

Layout table for additonal information
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 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
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