Not yet recruitingNCT06829186Updated Feb 17, 2025

The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients

A Phase 2 interventional study of Curcumin (Longvida™) and Placebo in Hemodialysis, sponsored by University of Guadalajara. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by University of Guadalajara · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.

Phase: Phase 2
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years to 100 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Hemodialysis

Browse trials for

Inflammation 3,536

Keywords

CURCUMIN
Hemodialysis
INFLAMMATION

In context

Inflammation

3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University of Guadalajara is the lead sponsor of 95 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 100 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I: No limits: ordinary activity causes no undue tiredness or breathlessness.
II: Slight limits: comfortable at rest, ordinary activity causes symptoms.
III: Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV: Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 70 participants (estimated)

Study arms

Experimental
case group
curcumin capsules 500 mg every 8 hours for 12 weeks
Dietary Supplement: Curcumin (Longvida™)
Placebo comparator
control group
placebo group
Drug: Placebo

Interventions

Dietary supplementCurcumin (Longvida™)
patients will be suplemented during 3 months with longvida, 2 cap /8 hours
DrugPlacebo
one capsules every 8 hours during 12 weeks

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 15385656 ↗
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. PubMed 28910790 ↗

Individual participant data

Plan to share: No — results will be used for future studies

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2025; primary completion for Sep 2025, 6 months later.

Of 113 non-industry phase 2 interventional studies under Inflammation, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's planned 6 months is below that.

Counting every sponsor, half of 149 studies reached it within 29 months; a quarter within 16 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 27, 2025
First posted: Feb 17, 2025
StartEst.: Mar 15, 2025
Primary completionEst.: Sep 30, 2025
CompletionEst.: Dec 30, 2026
Last update: Feb 17, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06829186
Lead sponsor: University of Guadalajara
Collaborators: Hospital Civil de Guadalajara
Responsible party: Mariana Chávez-Tostado (Doctor in Multidisciplinary Health Research, University of Guadalajara) — Principal investigator
First posted: Feb 17, 2025
Start date: Mar 15, 2025 (estimated)
Primary completion: Sep 30, 2025 (estimated)
Completion: Dec 30, 2026 (estimated)
Last update: Feb 17, 2025

Study contacts

Mariana Chávez-Tostado, PhD.

Contact

ln.marianachavez@gmail.com

3310585200 ext. 52

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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