NCT03475017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

February 21, 2018

Last Update Submit

December 14, 2023

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

  • Antioxidants and anti-inflammatory biomarkers

    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

    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

Study Arms (2)

Supplement A

ACTIVE COMPARATOR

Administration of 3 capsules with 500mg of curcumin and piperine per day, for 12 weeks

Dietary Supplement: Active Comparator: Supplement A

Supplement B

PLACEBO COMPARATOR

Administration of 3 capsules with 500mg of placebo (maize starch) per day, for 12 weeks

Dietary Supplement: Placebo Comparator: Supplement B

Interventions

Active Comparator: Supplement ADIETARY_SUPPLEMENT

The patients will receive 3 capsules per day containing 500mg of curcumin and 5mg of piperine for 4 weeks

Also known as: Curcumin and piperine
Supplement A
Placebo Comparator: Supplement BDIETARY_SUPPLEMENT

The patients will receive 3 capsules of placebo per day containing 500mg of maize starch for 4 weeks

Also known as: Placebo
Supplement B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Chronic Kidney Disease
  • Hemodialysis patients for more than 6 months
  • Aged 18 years or older
  • Must be able to swallow tablets

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

Related Publications (1)

  • Alvarenga L, Salarolli R, Cardozo LFMF, Santos RS, de Brito JS, Kemp JA, Reis D, de Paiva BR, Stenvinkel P, Lindholm B, Fouque D, Mafra D. Impact of curcumin supplementation on expression of inflammatory transcription factors in hemodialysis patients: A pilot randomized, double-blind, controlled study. Clin Nutr. 2020 Dec;39(12):3594-3600. doi: 10.1016/j.clnu.2020.03.007. Epub 2020 Mar 13.

    PMID: 32204978DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Curcuminpiperine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 23, 2018

Study Start

February 22, 2018

Primary Completion

April 29, 2021

Study Completion

December 30, 2021

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)