Clinical trial NCT06829186: The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients
Official title: Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hemodialysis
Keywords: CURCUMIN
Hemodialysis
INFLAMMATION
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Hospital Civil de Guadalajara
First posted: 2025-02-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Interleukin Interleukin-6
timeFrame: before supplementation
measure: Interleukin Interleukin-6
timeFrame: after 3 months of supplementation
measure: TNF-α: Tumor Necrosis Factor-alpha
timeFrame: before supplementation
measure: TNF-α: Tumor Necrosis Factor-alpha
timeFrame: after 3 months of supplementation
measure: IL-1β: Interleukin-1 beta
timeFrame: before supplementation
measure: IL-1β: Interleukin-1 beta
timeFrame: after 3 months of supplementation
Secondary outcomes:
measure: Urea
timeFrame: before supplementation
measure: Urea
timeFrame: after 3 months of supplementation
measure: leukocyte count
timeFrame: before supplementation
measure: leukocyte count
timeFrame: after 3 months of supplementation
measure: neutrophil/lymphocyte ratio (NLR)
timeFrame: before supplementation
measure: neutrophil/lymphocyte ratio (NLR)
timeFrame: after 3 months of supplementation
measure: lymphocyte/platelet ratio (LPR)
timeFrame: before supplementation
measure: lymphocyte/platelet ratio (LPR)
timeFrame: after 3 months of supplementation
measure: erythrocyte sedimentation rate (ESR)
timeFrame: before supplementation
measure: erythrocyte sedimentation rate (ESR)
timeFrame: after 3 months of supplementation
measure: serum albumin
timeFrame: before supplementation
measure: serum albumin
timeFrame: after 3 months of supplementation
measure: Weight
timeFrame: before supplementation
measure: Weight
timeFrame: after 3 months of supplementation
measure: body mass index (BMI)
timeFrame: before supplementation
measure: BMI
timeFrame: after 3 months of supplementation
measure: body fat percentage
timeFrame: before supplementation
measure: body fat percentage
timeFrame: after supplementation
measure: muscle mass
timeFrame: before supplementation
measure: muscle mass
timeFrame: after 3 months of supplementation
measure: hand grip strenght
timeFrame: before supplementation
measure: hand grip strenght
timeFrame: after 3 months of supplementation
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.