The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients

NCT ID: NCT06829186

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2026-12-30

Brief Summary

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.

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.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

case group

curcumin capsules 500 mg every 8 hours for 12 weeks

Group Type: EXPERIMENTAL

Curcumin (Longvida™)

Intervention Type: DIETARY_SUPPLEMENT

patients will be suplemented during 3 months with longvida, 2 cap /8 hours

control group

placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one capsules every 8 hours during 12 weeks

Interventions

Curcumin (Longvida™)

patients will be suplemented during 3 months with longvida, 2 cap /8 hours

Intervention Type: DIETARY_SUPPLEMENT

Placebo

one capsules every 8 hours during 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Civil de Guadalajara

OTHER

Sponsor Role: collaborator

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Mariana Chávez-Tostado

Doctor in Multidisciplinary Health Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mariana Chávez-Tostado, PhD.

Role: CONTACT

ln.marianachavez@gmail.com

3310585200 ext. 52

References

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.

Reference Type: BACKGROUND

PMID: 15385656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28910790 (View on PubMed)

Other Identifiers

CEI 100/25

Identifier Type: REGISTRY

Identifier Source: secondary_id

curcumin_hemodialysis

Identifier Type: -

Identifier Source: org_study_id