The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients

NCT06829186 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: curcumin_hemodialysisCEI 100/25
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis

Keywords

CURCUMIN; Hemodialysis; INFLAMMATION

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (22)

• Urea

  before supplementation

• Urea

  after 3 months of supplementation

• leukocyte count

  before supplementation

• leukocyte count

  after 3 months of supplementation

• neutrophil/lymphocyte ratio (NLR)

  before supplementation

Study Arms (2)

case group

EXPERIMENTAL

curcumin capsules 500 mg every 8 hours for 12 weeks

Dietary Supplement: Curcumin (Longvida™)

control group

PLACEBO COMPARATOR

placebo group

Drug: Placebo

Interventions

Curcumin (Longvida™) DIETARY_SUPPLEMENT

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

case group

Placebo DRUG

one capsules every 8 hours during 12 weeks

control group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guadalajara: lead
• Hospital Civil de Guadalajara: collaborator

Related Publications (2)

• 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.

  PMID: 15385656 BACKGROUND

• 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.

  PMID: 28910790 BACKGROUND

MeSH Terms

Conditions

Inflammation

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Central Study Contacts

Mariana Chávez-Tostado, PhD.

CONTACT

3310585200; ln.marianachavez@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Multidisciplinary Health Research

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 17, 2025
• Study Start: March 15, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share