Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 86 of 170 for:    curcumin

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 21, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE February 22, 2018
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03475017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Curcumin in Patients in Chronic Kidney Disease
Official Title  ICMJE Effects of Curcumin Supplementation in Inflammation, Oxidative Stress and Intestinal Microbiota in Patients With Chronic Kidney Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Kidney Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Supplement A
    Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks
    Intervention: Dietary Supplement: Active Comparator: Supplement A
  • Placebo Comparator: Supplement B
    Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks
    Intervention: Dietary Supplement: Placebo Comparator: Supplement B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475017
Other Study ID Numbers  ICMJE Denisemafra4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Denise Mafra, Universidade Federal Fluminense
Study Sponsor  ICMJE Denise Mafra
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal Fluminense
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP