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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases||Dietary Supplement: Active Comparator: Supplement A Dietary Supplement: Placebo Comparator: Supplement B||Not Applicable|
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.
Patients who accepted to participate in the study and who were included in the inclusion and exclusion criteria were randomized into two groups:
- 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.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
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
- 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)
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
|Rio de Janeiro, RJ, Brazil, 22260050|
|Contact: Denise Mafra, phd 21985683003 firstname.lastname@example.org|