The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients

Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients

The goal of this clinical trial is to learn if curcumin can lower the inflammation in participants with chronic kidney disease (CKD) undergoing hemodialysis (HD).

The main questions it aims to answer are:

Does curcumin lower can lower profinflamatory markers in participants with CKD on HD?

Researchers will compare curcumin to a placebo (a look-alike substance that contains no drug) to see if curcumin works to help the treatment in participants with CKD on HD.

Researchers will compare nutritional status and side effects after taking the supplement.

Participants will:

Take the curcumin or a placebo twice a day for 3 months Visit the clinic once every week for checkups and tests.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodialysis
• Intervention / Treatment: Dietary supplement: Curcumin (Longvida™); Drug: Placebo

Detailed Description

1. Study Title:

   "Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients"

2. Study Design:

   Type: Randomized, double-blind, placebo-controlled clinical trial.

   • Setting: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde," Mexico.
   • Participants: 34 CKD patients on hemodialysis or peritoneal dialysis, aged 18+.
   • Intervention: Patients will receive either curcumin (500 mg capsules, 3 times daily) or placebo for 12 weeks with pre- and post-intervention assessments.

3. Objectives:

   Primary Objective: To evaluate the effect of curcumin supplementation on inflammatory markers (TNF-α, IL-1β, IL-6, and CRP) in hemodialysis patients.

   Secondary Objectives:

   • To assess changes in renal metabolites (creatinine, urea, proteinuria).
   • To monitor nutritional status (weight, BMI, muscle mass, dynamometry).
   • To identify potential side effects or adverse reactions associated with curcumin supplementation.

4. Study Population:

   Inclusion Criteria:

   • Patients aged 18 years or older.
   • Clinically stable and receiving hemodialysis for at least 3 months prior to enrollment.
   • Willing to provide informed consent.

   Exclusion Criteria:

   • Active malignancy, severe infections, or systemic inflammatory diseases.
   • Liver disease (ALT/AST > 3x upper limit of normal).
   • Use of immunosuppressants, corticosteroids, or experimental drugs within the last month.
   • Pregnancy, smoking, or allergies to curcumin.
   • Recent antibiotic use (within the last 3 months).

5. Sample Size:

   Calculation: Based on a previous study (Afshar et al., 2020), a sample size of 17 patients per group (34 total) was determined to detect a significant difference in CRP levels with 80% power and a 20% dropout rate.

6. Randomization and Blinding:

   Randomization: Patients will be randomly assigned to either the curcumin or placebo group using sealed, opaque envelopes.

   Blinding: Both participants and investigators will be blinded to the treatment allocation. The placebo capsules will be identical in appearance to the curcumin capsules.

7. Intervention:

   • Curcumin Group: Patients will receive 500 mg curcumin capsules (Longvida® with 20% curcuminoids) two times daily (total of 1 g/day) for 12 weeks.
   • Placebo Group: Patients will receive identical-looking placebo capsules (containing starch) on the same schedule.

   Adherence Monitoring: Patients will be provided with a calendar to track capsule consumption. Adherence will be considered good if ≥80% of capsules are consumed.

8. Data Collection:

   • Baseline and Post-Intervention Assessments:
   • Inflammatory Markers: TNF-α, IL-1β, IL-6, and CRP levels will be measured using ELISA.
   • Renal Function: Serum creatinine, urea, proteinuria, and other renal markers will be assessed.
   • Nutritional Status: Weight, height, BMI, body composition (fat and muscle mass), and handgrip strength (dynamometry) will be measured.
   • Dietary Habits: A 3-day dietary diary will be used to assess protein, fat, fiber, sodium, potassium, and phosphorus intake.
   • Adverse Events: Any side effects or adverse reactions will be recorded during weekly follow-ups.

9. Laboratory Procedures:

   • Blood Samples: Collected before and after the intervention. Samples will be centrifuged and stored at -80°C for biomarker analysis.
   • ELISA Analysis: Inflammatory markers (TNF-α, IL-1β, IL-6, CRP) will be quantified using commercially available ELISA kits.
   • Renal Function Tests: Performed in the hospital's clinical laboratory using standard methods.

10. Statistical Analysis:

    -Descriptive Statistics: Mean, median, standard deviation, and frequencies will -be calculated for continuous and categorical variables.

    Inferential Statistics:

    • Normality will be assessed using Kolmogorov-Smirnov or Shapiro-Wilk tests.
    • Parametric tests (t-tests) or non-parametric tests (Mann-Whitney U) will be used to compare groups.
    • Chi-square or Fisher's exact tests will be used for categorical variables.
    • Changes in inflammatory markers and renal function will be analyzed using paired tests (pre- vs. post-intervention).

    Software: SPSS (version 17.0) and GraphPad Prism (version 10.3.0) will be used for data analysis.

11. Ethical Considerations:

    • Approval: The study protocol has been approved by the Ethics Committee of the Antiguo Hospital Civil de Guadalajara.
    • Informed Consent: All participants will provide written informed consent before enrollment.
    • Confidentiality: Patient data will be anonymized and stored securely. Only the research team will have access to identifiable information.
    • Participant Rights: Participation is voluntary, and patients may withdraw at any time without affecting their medical care.

12. Timeline:

    • May-Oct 2024: Literature review and protocol development.
    • Jan-Mar 2025: Ethical approval and patient recruitment.
    • Mar-Dec 2026: Intervention period and data collection.
    • Dec 2026: Data analysis and manuscript preparation.
    • 2027: Publication and dissemination of results.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mariana Chávez-Tostado, PhD.; Phone Number: 52 3310585200; Email: ln.marianachavez@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients of both sexes undergoing dialysis or hemodialysis.
• Aged 18 years or older.
• Clinically stable and receiving hemodialysis or dialysis for at least three months before study enrollment.
• Continuation of pharmacotherapy as prescribed by their physician.
• Regular use of antioxidant supplements and turmeric consumption.
• Signed written informed consent.

Exclusion Criteria:

• Active malignant disease (diagnosed within the past five years).
• Critical illness requiring respiratory or circulatory support.
• Severe congestive heart failure (NYHA class IV).
• Severe chronic systemic infectious or inflammatory disease.
• Severe liver disease.
• Known allergy to study products.
• Treatment with immunosuppressants or experimental drugs in the past month.
• Use of anti-inflammatory corticosteroids.
• Scheduled kidney transplant during the study.
• Pregnant patients.
• Active smokers.
• Autoimmune diseases, cancer, severe infections, or AIDS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: case group; curcumin capsules 500 mg every 8 hours for 12 weeks	Dietary supplement: Curcumin (Longvida™); patients will be suplemented during 3 months with longvida, 2 cap /8 hours
Placebo Comparator: control group; placebo group	Drug: Placebo; one capsules every 8 hours during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin Interleukin-6	basal meassurement of Interleukin-6 in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)	before supplementation
Interleukin Interleukin-6	final meassurement of Interleukin-6 nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)	after 3 months of supplementation
TNF-α: Tumor Necrosis Factor-alpha	basal meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)	before supplementation
TNF-α: Tumor Necrosis Factor-alpha	final meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)	after 3 months of supplementation
IL-1β: Interleukin-1 beta	basal meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)	before supplementation
IL-1β: Interleukin-1 beta	final meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)	after 3 months of supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urea	Urea meassurement in mg/dL using a biochemistry analyzer	before supplementation
Urea	Urea meassurement in mg/dL using a biochemistry analyzer	after 3 months of supplementation
leukocyte count	leukocyte count (cells/µL) using an automated blood cell counter	before supplementation
leukocyte count	leukocyte count (cells/µL) using an automated blood cell counter	after 3 months of supplementation
neutrophil/lymphocyte ratio (NLR)	NLR (neutrophil/lymphocyte count) using a hematology analyzer.	before supplementation
neutrophil/lymphocyte ratio (NLR)	NLR (neutrophil/lymphocyte count) using a hematology analyzer.	after 3 months of supplementation
lymphocyte/platelet ratio (LPR)	LPR (lymphocyte/platelet count) using a hematology analyzer.	before supplementation
lymphocyte/platelet ratio (LPR)	LPR (lymphocyte/platelet count) using a hematology analyzer.	after 3 months of supplementation
erythrocyte sedimentation rate (ESR)	ESR (mm/h) using a Westergren ESR analyzer	before supplementation
erythrocyte sedimentation rate (ESR)	ESR (mm/h) using a Westergren ESR analyzer	after 3 months of supplementation
serum albumin	serum albumin in g/dL using a biochemistry analyzer	before supplementation
serum albumin	serum albumin in g/dL using a biochemistry analyzer	after 3 months of supplementation
Weight	Weight of partipants (kg) using a tanita BC 601® scale	before supplementation
Weight	Weight of partipants (kg) using a tanita BC 601® scale	after 3 months of supplementation
body mass index (BMI)	BMI of patients (weight/height*height)	before supplementation
BMI	BMI of patients (weight/height*height)	after 3 months of supplementation
body fat percentage	body fat percentage of patients (%) using a tanita BC 601® scale	before supplementation
body fat percentage	body fat percentage of patients (%) using a tanita BC 601® scale	after supplementation
muscle mass	muscle mass of patients (kg) using a tanita BC 601® scale	before supplementation
muscle mass	muscle mass of patients (kg) using a tanita BC 601® scale	after 3 months of supplementation
hand grip strenght	hand grip strenght of patients using a dynamometer (kg), (Jamar Plus Digital Hand Dynamometer)	before supplementation
hand grip strenght	hand grip strenght of patients using a dynamometer (kg), (Jamar Plus Digital Hand Dynamometer)	after 3 months of supplementation

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Collaborators: Hospital Civil de Guadalajara

Publications and helpful links

General Publications

• Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031. Erratum In: N Engl J Med. 2008;18(4):4.
• Cozzolino M, Galassi A, Pivari F, Ciceri P, Conte F. The Cardiovascular Burden in End-Stage Renal Disease. Contrib Nephrol. 2017;191:44-57. doi: 10.1159/000479250. Epub 2017 Sep 14.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Hemodialysis; INFLAMMATION; CURCUMIN
• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Curcumin
• Other Study ID Numbers: curcumin_hemodialysis; CEI 100/25 (Registry Identifier: CUR/HEMOD-FAA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: results will be used for future studies

Drug and device information, study documents

• 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.: Yes