HemodialysisPhase 2NCT06829186
The Effect of Curcumin on Inflammatory Markers in Hemodialysis Patients
A Phase 2 study testing Curcumin (Longvida™) in people with Hemodialysis, run by University of Guadalajara.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Curcumin (Longvida™)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients
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
- Hemodialysis
- Being tested
- Curcumin (Longvida™), Placebo
- Keywords
- CURCUMIN, Hemodialysis, INFLAMMATION
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin (Longvida™)Dietary supplement
patients will be suplemented during 3 months with longvida, 2 cap /8 hours
PlaceboDrug
one capsules every 8 hours during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | curcumin capsules 500 mg every 8 hours for 12 weeks Receives: Dietary Supplement: Curcumin (Longvida™) |
| control group | Placebo comparator | placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin Interleukin-6
basal meassurement of Interleukin-6 in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: before supplementation
Interleukin Interleukin-6
final meassurement of Interleukin-6 nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: 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)
Measured: before supplementation
TNF-α: Tumor Necrosis Factor-alpha
final meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: after 3 months of supplementation
IL-1β: Interleukin-1 beta
basal meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: before supplementation
IL-1β: Interleukin-1 beta
final meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: after 3 months of supplementation
Secondary outcomes (22)
Urea
Urea meassurement in mg/dL using a biochemistry analyzer
Measured: before supplementation
Urea
Urea meassurement in mg/dL using a biochemistry analyzer
Measured: after 3 months of supplementation
leukocyte count
leukocyte count (cells/µL) using an automated blood cell counter
Measured: before supplementation
leukocyte count
leukocyte count (cells/µL) using an automated blood cell counter
Measured: after 3 months of supplementation
neutrophil/lymphocyte ratio (NLR)
NLR (neutrophil/lymphocyte count) using a hematology analyzer.
Measured: before supplementation
neutrophil/lymphocyte ratio (NLR)
NLR (neutrophil/lymphocyte count) using a hematology analyzer.
Measured: after 3 months of supplementation
lymphocyte/platelet ratio (LPR)
LPR (lymphocyte/platelet count) using a hematology analyzer.
Measured: before supplementation
lymphocyte/platelet ratio (LPR)
LPR (lymphocyte/platelet count) using a hematology analyzer.
Measured: after 3 months of supplementation
erythrocyte sedimentation rate (ESR)
ESR (mm/h) using a Westergren ESR analyzer
Measured: before supplementation
erythrocyte sedimentation rate (ESR)
ESR (mm/h) using a Westergren ESR analyzer
Measured: after 3 months of supplementation
serum albumin
serum albumin in g/dL using a biochemistry analyzer
Measured: before supplementation
serum albumin
serum albumin in g/dL using a biochemistry analyzer
Measured: after 3 months of supplementation
Weight
Weight of partipants (kg) using a tanita BC 601® scale
Measured: before supplementation
Weight
Weight of partipants (kg) using a tanita BC 601® scale
Measured: after 3 months of supplementation
body mass index (BMI)
BMI of patients (weight/height*height)
Measured: before supplementation
BMI
BMI of patients (weight/height*height)
Measured: after 3 months of supplementation
body fat percentage
body fat percentage of patients (%) using a tanita BC 601® scale
Measured: before supplementation
body fat percentage
body fat percentage of patients (%) using a tanita BC 601® scale
Measured: after supplementation
muscle mass
muscle mass of patients (kg) using a tanita BC 601® scale
Measured: before supplementation
muscle mass
muscle mass of patients (kg) using a tanita BC 601® scale
Measured: after 3 months of supplementation
hand grip strenght
hand grip strenght of patients using a dynamometer (kg), (Jamar Plus Digital Hand Dynamometer)
Measured: before supplementation
hand grip strenght
hand grip strenght of patients using a dynamometer (kg), (Jamar Plus Digital Hand Dynamometer)
Measured: after 3 months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Civil de Guadalajara
- Responsible party
- Principal investigator, Mariana Chávez-Tostado, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829186
- Sponsor's protocol ID
- curcumin_hemodialysis
- Other IDs
- CEI 100/25
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results will be used for future studies
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.
PubMed 15385656Cozzolino 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Curcumin on the Reduction of Cellular Inflammation Markers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06829186
- Acronym / sponsor ID
- curcumin_hemodialysis
- Conditions
- Hemodialysis
- Keywords
- CURCUMIN, Hemodialysis, INFLAMMATION
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Hospital Civil de Guadalajara
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Dietary Supplement: Curcumin (Longvida™)curcumin capsules 500 mg every 8 hours for 12 weeks |
| control group | Placebo comparator | Drug: Placeboplacebo group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin (Longvida™)patients will be suplemented during 3 months with longvida, 2 cap /8 hours | Dietary supplement | case group |
| Placeboone capsules every 8 hours during 12 weeks | Drug | control group |
Primary outcome
Interleukin Interleukin-6
Time frame: before supplementation
basal meassurement of Interleukin-6 in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
Interleukin Interleukin-6
Time frame: after 3 months of supplementation
final meassurement of Interleukin-6 nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
TNF-α: Tumor Necrosis Factor-alpha
Time frame: before supplementation
basal meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
TNF-α: Tumor Necrosis Factor-alpha
Time frame: after 3 months of supplementation
final meassurement of TNF-α in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
IL-1β: Interleukin-1 beta
Time frame: before supplementation
basal meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
IL-1β: Interleukin-1 beta
Time frame: after 3 months of supplementation
final meassurement of IL-1β in nanometers using the Enzyme-Linked Immunosorbent Assay (ELISA)
22 secondary outcomes
Urea
Time frame: before supplementation
Urea
Time frame: after 3 months of supplementation
leukocyte count
Time frame: before supplementation
leukocyte count
Time frame: after 3 months of supplementation
neutrophil/lymphocyte ratio (NLR)
Time frame: before supplementation
neutrophil/lymphocyte ratio (NLR)
Time frame: after 3 months of supplementation
lymphocyte/platelet ratio (LPR)
Time frame: before supplementation
lymphocyte/platelet ratio (LPR)
Time frame: after 3 months of supplementation
erythrocyte sedimentation rate (ESR)
Time frame: before supplementation
erythrocyte sedimentation rate (ESR)
Time frame: after 3 months of supplementation
serum albumin
Time frame: before supplementation
serum albumin
Time frame: after 3 months of supplementation
Weight
Time frame: before supplementation
Weight
Time frame: after 3 months of supplementation
body mass index (BMI)
Time frame: before supplementation
BMI
Time frame: after 3 months of supplementation
body fat percentage
Time frame: before supplementation
body fat percentage
Time frame: after supplementation
muscle mass
Time frame: before supplementation
muscle mass
Time frame: after 3 months of supplementation
hand grip strenght
Time frame: before supplementation
hand grip strenght
Time frame: after 3 months of supplementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 15385656Go 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.
- Background: PubMed 28910790Cozzolino 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.
- Individual participant dataSharing planned: No. results will be used for future studies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin (Longvida™) in people with Hemodialysis, run by University of Guadalajara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Chávez-Tostado, PhD. (3310585200 ext. 52, ln.marianachavez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin Interleukin-6 (time frame: before supplementation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829186, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.