血液透析患者の炎症マーカーに対するクルクミンの効果

Study Title:

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.