Chronic Kidney DiseasesPhase 2NCT03223883
Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease
A Phase 2 study testing Curcumin in people with Chronic Kidney Diseases and Cognitive Decline, run by Diana Jalal at 1 site in United States.
Trial summary
The proposed research is clinical study evaluating the therapeutic benefits of curcumin on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that curcumin will improve endothelial function and reduce large artery stiffness by reducing oxidative stress and in conjunction with… Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Chronic Kidney Diseases, Cognitive Decline
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 25 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage IIIB and IV
- BMI<35 kg/m2
- Able to give informed consent
Who cannot join
- Consuming a diet rich in curcumin or taking curcumin supplements in the past 12 months
- Life expectancy <1 year
- Pregnant, breastfeeding, or unwilling to use adequate birth control
- Uncontrolled hypertension
- Severe liver disease
- Severe congestive heart failure
Show all 9Show fewer
- Hospitalization within the last 3 months
- Active infection or antibiotic therapy
- Immunosuppressive therapy within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Curcumin Supplementation for Improving Vascular and Cognitive Function in Chronic Kidney Disease
The proposed research is clinical study evaluating the therapeutic benefits of curcumin on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that curcumin will improve endothelial function and reduce large artery stiffness by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in patients with CKD.
Read the detailed description
Patients with chronic kidney disease (CKD) are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment in CKD are a biomedical priority.
Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. It is safe and widely-available. Preliminary data in old mice and healthy middle-aged (MA)/older adult humans indicate that curcumin administration improves endothelial dysfunction and large artery stiffness by reducing oxidative stress and inflammation. Additionally, 12 weeks of curcumin supplementation improves episodic memory in MA/older adults.
The primary goal of this R01 application is to extend previous findings in healthy MA/older adults to patients with CKD, a growing clinical population with extensive baseline vascular dysfunction and cognitive impairment who presently have few treatment options. The hypothesis is that curcumin improves vascular endothelial function and large elastic artery stiffness in MA/older adults with stage IIIb and IV CKD (estimated GFR 15-45 mL/min/1.73m2). The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.
Specific aim 1a will determine if 12 months of curcumin supplementation will improve brachial artery-flow mediated dilation (BA-FMD) (endothelial function) and aortic pulse wave velocity (aPWV) (arterial stiffness) compared to placebo (randomized placebo-controlled double-blind study). Specific aim 1b will evaluate whether the curcumin-induced improvements in BA-FMD and aPWV are mediated by reduced oxidative stress, and will evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress. Importantly, specific aim 2 will evaluate the effects of curcumin supplementation on cognitive function, an important complication of CKD, using the NIH Cognitive Toolbox Battery.
- Conditions
- Chronic Kidney Diseases, Cognitive Decline
- Being tested
- Curcumin, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Longvida
Oral supplement for 12 months
PlaceboOther
Oral placebo for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | Patients will receive curcumin (Lonvida) 2000 mg PO once a day Receives: Drug: Curcumin |
| Placebo | Placebo comparator | Patients will receive placebo pill identical in appearance and taste to the supplement Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vascular Endothelial Function at 12 Months
Brachial artery flow-mediated dilation, changed in diameter in brachial artery in response to shear stress
Measured: 12 months
Secondary outcomes (2)
Large Artery Stiffness
Aortic pulse wave velocity
Measured: 12 months
Cognitive Function
NIH toolbox battery- Executive Function Age-Corrected Standard Score is reported (T-score): This score compares the score of the test-taker to those in the NIH Toolbox nationally representative normative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. Age-corrected standard scores were derived separately for children (ages 3-17) and adults (ages 18-85). A score of 115 or 85, for example, would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants. Higher scores indicate better performance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jun 2018
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseasesStudies 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
- Model description
- Randomized Double-Blind Placebo-Controlled Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana Jalal
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder, Stanford University, University of Colorado, Denver
- Responsible party
- Sponsor-investigator, Diana Jalal, University of Iowa
- Investigators
- Diana Jalal, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223883
- Sponsor's protocol ID
- 201710769
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2017
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Supplementation for Improving Vascular and Cognitive Function in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03223883
- Acronym / sponsor ID
- 201710769
- Conditions
- Chronic Kidney Diseases, Cognitive Decline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Diana JalalUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder, Stanford University, University of Colorado, Denver
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research is clinical study evaluating the therapeutic benefits of curcumin on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that curcumin will improve endothelial function and reduce large artery stiffness by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in patients with CKD.
Detailed description
Patients with chronic kidney disease (CKD) are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment in CKD are a biomedical priority.
Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. It is safe and widely-available. Preliminary data in old mice and healthy middle-aged (MA)/older adult humans indicate that curcumin administration improves endothelial dysfunction and large artery stiffness by reducing oxidative stress and inflammation. Additionally, 12 weeks of curcumin supplementation improves episodic memory in MA/older adults.
The primary goal of this R01 application is to extend previous findings in healthy MA/older adults to patients with CKD, a growing clinical population with extensive baseline vascular dysfunction and cognitive impairment who presently have few treatment options. The hypothesis is that curcumin improves vascular endothelial function and large elastic artery stiffness in MA/older adults with stage IIIb and IV CKD (estimated GFR 15-45 mL/min/1.73m2). The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.
Specific aim 1a will determine if 12 months of curcumin supplementation will improve brachial artery-flow mediated dilation (BA-FMD) (endothelial function) and aortic pulse wave velocity (aPWV) (arterial stiffness) compared to placebo (randomized placebo-controlled double-blind study). Specific aim 1b will evaluate whether the curcumin-induced improvements in BA-FMD and aPWV are mediated by reduced oxidative stress, and will evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress. Importantly, specific aim 2 will evaluate the effects of curcumin supplementation on cognitive function, an important complication of CKD, using the NIH Cognitive Toolbox Battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double-Blind Placebo-Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: CurcuminPatients will receive curcumin (Lonvida) 2000 mg PO once a day |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive placebo pill identical in appearance and taste to the supplement |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD stage IIIB and IV
- BMI<35 kg/m2
- Able to give informed consent
Key exclusion criteria (9 listed)
- Consuming a diet rich in curcumin or taking curcumin supplements in the past 12 months
- Life expectancy <1 year
- Pregnant, breastfeeding, or unwilling to use adequate birth control
- Uncontrolled hypertension
- 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 |
|---|---|---|
| CurcuminAlso: LongvidaOral supplement for 12 months | Drug | Curcumin |
| PlaceboOral placebo for 12 months | Other | Placebo |
Primary outcome
Change in Vascular Endothelial Function at 12 Months
Time frame: 12 months
Brachial artery flow-mediated dilation, changed in diameter in brachial artery in response to shear stress
2 secondary outcomes
Large Artery Stiffness
Time frame: 12 months
Cognitive Function
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Diana Jalal principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin in people with Chronic Kidney Diseases and Cognitive Decline, run by Diana Jalal at 1 site in United States.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vascular Endothelial Function at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2024.