Uric AcidNCT04960527
Acute Effects of Tart Cherry on Uric Acid and Biomarkers of CVD Risk in Healthy Individuals
A study testing Tart cherry juice and Water in people with Uric Acid and Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
This study aims to provide evidence as to whether consumption of tart cherry juice can reduce the risk of gout and cardiovascular disease (CVD) in an acute context. The proposed study is a 2-way cross-over, randomised, placebo-controlled trial and aims to answer the following research questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Uric Acid, Cardiovascular Diseases, Gout
- What is being tested?
- Tart cherry juice and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jul 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or over
- able and willing to participate in the study and provide written informed consent
Who cannot join
- current smoker
- any known food allergies/intolerances
- history of medical conditions, including gastrointestinal disease, severe renal impairment (estimated glomerular filtration rate of <30ml/min) or renal disease, cardiovascular disease, diabetes (type 1 or type 2) and gout
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Food and Nutrition Group, Sheffield Hallam University
Sheffield, S1 1WB
About this study
Official title: The Acute Effects of Tart Cherry Juice on Uric Acid and Biomarkers of Cardiovascular Disease Risk in Healthy Individuals
This study aims to provide evidence as to whether consumption of tart cherry juice can reduce the risk of gout and cardiovascular disease (CVD) in an acute context. The proposed study is a 2-way cross-over, randomised, placebo-controlled trial and aims to answer the following research questions:
- What effect does a single 30mL serving of tart cherry concentrate have on serum uric acid and urinary excretion of uric acid in healthy individuals, when compared with water?
- What effect does a single 30mL serving of tart cherry concentrate have on markers of cardiovascular disease risk and oxidative stress in healthy individuals, when compared with water?
By measuring acute changes in serum urate, fractional urinary urate excretion, inflammatory markers, oxidative stress markers and CVD risk markers (namely central and brachial blood pressure, and arterial stiffness), it will highlight possible mechanisms through which tart cherry may reduce risk of gout and/or CVD.
Read the detailed description
Healthy, non-smoking, adult volunteers (n = 15) will be recruited to a 2-way cross-over, randomized, placebo-controlled study.
A sample size of 13 has been calculated using data from White et al. (2018), using the primary outcome of change in serum uric acid level. Between-person variations in serum urate was established at approximately 50 µmol/L. Within-subject variation to apple juice was approximately 35 µmol/L. It has been estimated that cherry juice will produce a fall in serum urate of approximately 15 µmol/L (Jacob et al., 2003). Therefore, 13 participants will be needed to detect this change with 80% power at an alpha level of 0.05.
Participants will avoid strenuous exercise for 72-hours prior to the study until 24-hours post-consumption of the test drinks; compliance will be assessed through completion of a physical activity diary. They will also follow a low-polyphenolic diet for 48-hours prior to the study until 24-hours post-consumption of the test drinks; participants will be provided with a list of foods/drinks to avoid and compliance will be assessed through completion of a food diary. Participants will be provided with instructions of foods to avoid and a low polyphenolic pasta ready-meal, dessert and low nitrate water to consume the evening preceding the study day.
Participants will attend the laboratory following an overnight fast. Blood pressure (central and brachial) and arterial stiffness will be measured using a non-invasive Vicorder device. A venepuncture blood sample will be collected by a researcher trained in phlebotomy before consumption of the test drink. Approximately 10 ml of blood will be taken during each venepuncture. A urine sample will also be collected. Participants will consume 250 ml of tart cherry juice or neutral control (water) on two occasions, at least one week apart; the sequence order will be random. The cherry juice comprises 30 mL tart cherry concentrate diluted with 220 mL water. Further venous blood samples will be taken at 1 and 2 hours post-consumption. These will be supplemented with finger-prick samples collected at 3, 5 and 24 hours post drink. Post-drink measures of arterial stiffness will be taken at 1, 2, 3, 5 and 24-hours post-consumption. Additional urine samples will also be collected between 0-2, 2-4, 4-5, 5-8, 8-11, and 11-24 hours, post-consumption of the test drinks. Participants' water intake during each laboratory visit will be standardised at 500 ml. Participants will be provided with a low-polyphenolic sandwich lunch, pasta ready-meal dinner, dessert, snacks and low nitrate water to consume following the 5-hour measurements. Participants will return to the laboratory the next morning following a 12-hour fast for their 24-hour measurements.
Blood will be analysed for serum uric acid and creatinine concentrations at all time points and for CRP (a measure of inflammation) at baseline, 2, and 5 hours, post-drink. White blood cells (lymphocytes) will be separated from whole venous blood samples collected at baseline, 1 and 2-hours post-drink consumption for the analysis of oxidative DNA damage. Urine samples will be analysed for uric acid and creatinine to calculate fractional excretion of urinary uric acid (using a commercial colorimetric assay). Polyphenolic metabolites from the test drink will also be analysed in urine samples.
Data analysis: The effect of the treatment (tart cherry versus water) on all outcome variables will be analysed with 2-way repeated measures ANOVAs. A statistical significance level of P≤ 0.05 will be set.
- Conditions
- Uric Acid, Cardiovascular Diseases, Gout
- Being tested
- Tart cherry juice, Water
- Medical subject headings
- Cardiovascular Diseases, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart cherry juiceDietary supplement
250 mL tart cherry juice (30 mL tart cherry concentrate [CherryActive, UK] diluted with 220 mL water) is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit.
WaterOther
250 mL water is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit.
| Study group | Role | What they receive |
|---|---|---|
| Tart cherry juice | Experimental | 30 mL tart cherry concentrate (CherryActive, UK, 100% Montmorency) diluted with 220 mL water (totalling 250 mL). According to available manufacturers data, this is equivalent to consuming 90-100 fresh cherries. Receives: Dietary Supplement: Tart cherry juice |
| Water | Other | 250 mL water (neutral control) Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum urate (in millimoles per litre (mmol/l)
Difference in serum urate in tart cherry juice arm versus water arm from baseline to 24 hours post-consumption of drink. Measured using a commercial fluorometric/colorimetric urate assay kit.
Measured: Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink
Secondary outcomes (7)
Change in urinary urate (mmol/l)
Difference in urinary urate in tart cherry juice arm versus water arm from baseline to 24 hours post-drink consumption. Measured using a commercial fluorometric/colorimetric assay kit
Measured: Measured from samples collected at baseline and between 0-2 hours, 2-4 hours, 4-5 hours, 5-8 hours, 8-11 hours and 11-24 hours
Change in urinary creatinine (mmol/l)
Difference in urinary creatinine in tart cherry juice arm versus water arm from baseline hours to 24 hours post-drink consumption. Measured using a commercial fluorometric/colorimetric assay kit
Measured: Measured from samples collected at baseline and between 0-2 hours, 2-4 hours, 4-5 hours, 5-8 hours, 8-11 hours and 11-24 hours
Change in serum creatinine (mmol/l)
Difference in serum creatinine in tart cherry juice arm versus water arm from baseline to 24 hours post-drink consumption. Measured using a commercial fluorometric/colorimetric assay kit
Measured: Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink
Change in c reactive protein (in milligrams per litre (mg/l)
Difference in serum c reactive protein (CRP) in tart cherry juice arm versus water arm from baseline to 5 hours post-consumption of drink. Measured using an enzyme-linked immunosorbent assay (ELISA).
Measured: Measured at baseline, 2 and 5 hours post-consumption of test drink
Change in blood pressure (in millimetres of mercury (mmHg))
Difference in brachial and central blood pressure in tart cherry juice arm versus water arm from baseline to 24 hours post-consumption of drink. Measured using a Vicorder non-invasive device.
Measured: Measured at baseline, 1, 2, 3, 5, and 24-hours post-consumption of test drink
Change in arterial stiffness (Augmentation index measured in %, pulse wave velocity measured in meters per second (m/s))
Difference in augmentation index (AI) and pulse wave velocity (PWV) in tart cherry juice arm versus water arm from baseline to 24 hours post-consumption of drink. Measured using a Vicorder non-invasive device.
Measured: Measured at baseline, 1, 2, 3, 5, and 24-hours post-consumption of test drink
Change in oxidative damage (in percentage (%) of tail DNA)
Difference in markers of oxidative stress in tart cherry juice arm versus water arm from baseline to 2 hours post-consumption of drink. Measured using single-cell electrophoresis 'comet assay' as 8-oxo-dg levels in lymphocytes.
Measured: Measured at baseline, 1 and 2 hours post-consumption of test drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start10 Jul 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Uric AcidStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-way crossover, randomised controlled trial. Participants will be allocated to consume tart cherry juice or a neutral water control on separate occasions. The order of this allocation will be randomised.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Lynn, Sheffield Hallam University
- Investigators
- Tony Lynn, PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960527
- Sponsor's protocol ID
- ER9199256
- Status last verified
- Jun 2024
- First submitted
- 2 Jul 2021
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. doi: 10.1093/jn/133.6.1826.
PubMed 12771324White SJ, Carran EL, Reynolds AN, Haszard JJ, Venn BJ. The effects of apples and apple juice on acute plasma uric acid concentration: a randomized controlled trial. Am J Clin Nutr. 2018 Feb 1;107(2):165-172. doi: 10.1093/ajcn/nqx059.
PubMed 29529161Lynn A, Mathew S, Moore CT, Russell J, Robinson E, Soumpasi V, Barker ME. Effect of a tart cherry juice supplement on arterial stiffness and inflammation in healthy adults: a randomised controlled trial. Plant Foods Hum Nutr. 2014 Jun;69(2):122-7. doi: 10.1007/s11130-014-0409-x.
PubMed 24570273Chai SC , Davis K , Wright RS , Kuczmarski MF , Zhang Z . Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. Food Funct. 2018 Jun 20;9(6):3185-3194. doi: 10.1039/c8fo00468d.
PubMed 29862410Bell, P. G., Gaze, D. C., Davison, G. W., George, T. W., Scotter, M. J., & Howatson, G. (2014). Montmorency tart cherry (Prunus cerasus L.) concentrate lowers uric acid, independent of plasma cyanidin-3-O-glucosiderutinoside. Journal of Functional Foods, 11, 82-90.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Tart Cherry Juice on Uric Acid and Biomarkers of Cardiovascular Disease Risk in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04960527
- Acronym / sponsor ID
- ER9199256
- Conditions
- Uric Acid, Cardiovascular Diseases, Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 Jul 2021 (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.
This study aims to provide evidence as to whether consumption of tart cherry juice can reduce the risk of gout and cardiovascular disease (CVD) in an acute context. The proposed study is a 2-way cross-over, randomised, placebo-controlled trial and aims to answer the following research questions:
- What effect does a single 30mL serving of tart cherry concentrate have on serum uric acid and urinary excretion of uric acid in healthy individuals, when compared with water?
- What effect does a single 30mL serving of tart cherry concentrate have on markers of cardiovascular disease risk and oxidative stress in healthy individuals, when compared with water?
By measuring acute changes in serum urate, fractional urinary urate excretion, inflammatory markers, oxidative stress markers and CVD risk markers (namely central and brachial blood pressure, and arterial stiffness), it will highlight possible mechanisms through which tart cherry may reduce risk of gout and/or CVD.
Detailed description
Healthy, non-smoking, adult volunteers (n = 15) will be recruited to a 2-way cross-over, randomized, placebo-controlled study.
A sample size of 13 has been calculated using data from White et al. (2018), using the primary outcome of change in serum uric acid level. Between-person variations in serum urate was established at approximately 50 µmol/L. Within-subject variation to apple juice was approximately 35 µmol/L. It has been estimated that cherry juice will produce a fall in serum urate of approximately 15 µmol/L (Jacob et al., 2003). Therefore, 13 participants will be needed to detect this change with 80% power at an alpha level of 0.05.
Participants will avoid strenuous exercise for 72-hours prior to the study until 24-hours post-consumption of the test drinks; compliance will be assessed through completion of a physical activity diary. They will also follow a low-polyphenolic diet for 48-hours prior to the study until 24-hours post-consumption of the test drinks; participants will be provided with a list of foods/drinks to avoid and compliance will be assessed through completion of a food diary. Participants will be provided with instructions of foods to avoid and a low polyphenolic pasta ready-meal, dessert and low nitrate water to consume the evening preceding the study day.
Participants will attend the laboratory following an overnight fast. Blood pressure (central and brachial) and arterial stiffness will be measured using a non-invasive Vicorder device. A venepuncture blood sample will be collected by a researcher trained in phlebotomy before consumption of the test drink. Approximately 10 ml of blood will be taken during each venepuncture. A urine sample will also be collected. Participants will consume 250 ml of tart cherry juice or neutral control (water) on two occasions, at least one week apart; the sequence order will be random. The cherry juice comprises 30 mL tart cherry concentrate diluted with 220 mL water. Further venous blood samples will be taken at 1 and 2 hours post-consumption. These will be supplemented with finger-prick samples collected at 3, 5 and 24 hours post drink. Post-drink measures of arterial stiffness will be taken at 1, 2, 3, 5 and 24-hours post-consumption. Additional urine samples will also be collected between 0-2, 2-4, 4-5, 5-8, 8-11, and 11-24 hours, post-consumption of the test drinks. Participants' water intake during each laboratory visit will be standardised at 500 ml. Participants will be provided with a low-polyphenolic sandwich lunch, pasta ready-meal dinner, dessert, snacks and low nitrate water to consume following the 5-hour measurements. Participants will return to the laboratory the next morning following a 12-hour fast for their 24-hour measurements.
Blood will be analysed for serum uric acid and creatinine concentrations at all time points and for CRP (a measure of inflammation) at baseline, 2, and 5 hours, post-drink. White blood cells (lymphocytes) will be separated from whole venous blood samples collected at baseline, 1 and 2-hours post-drink consumption for the analysis of oxidative DNA damage. Urine samples will be analysed for uric acid and creatinine to calculate fractional excretion of urinary uric acid (using a commercial colorimetric assay). Polyphenolic metabolites from the test drink will also be analysed in urine samples.
Data analysis: The effect of the treatment (tart cherry versus water) on all outcome variables will be analysed with 2-way repeated measures ANOVAs. A statistical significance level of P≤ 0.05 will be set.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-way crossover, randomised controlled trial. Participants will be allocated to consume tart cherry juice or a neutral water control on separate occasions. The order of this allocation will be randomised.
| Arm | Type | Receives |
|---|---|---|
| Tart cherry juice | Experimental | Dietary Supplement: Tart cherry juice30 mL tart cherry concentrate (CherryActive, UK, 100% Montmorency) diluted with 220 mL water (totalling 250 mL). According to available manufacturers data, this is equivalent to consuming 90-100 fresh cherries. |
| Water | Other | Other: Water250 mL water (neutral control) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 years or over
- able and willing to participate in the study and provide written informed consent
Key exclusion criteria (3 listed)
- current smoker
- any known food allergies/intolerances
- history of medical conditions, including gastrointestinal disease, severe renal impairment (estimated glomerular filtration rate of <30ml/min) or renal disease, cardiovascular disease, diabetes (type 1 or type 2) and gout
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 |
|---|---|---|
| Tart cherry juice250 mL tart cherry juice (30 mL tart cherry concentrate [CherryActive, UK] diluted with 220 mL water) is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit. | Dietary supplement | Tart cherry juice |
| Water250 mL water is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit. | Other | Water |
Primary outcome
Change in serum urate (in millimoles per litre (mmol/l)
Time frame: Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink
Difference in serum urate in tart cherry juice arm versus water arm from baseline to 24 hours post-consumption of drink. Measured using a commercial fluorometric/colorimetric urate assay kit.
7 secondary outcomes
Change in urinary urate (mmol/l)
Time frame: Measured from samples collected at baseline and between 0-2 hours, 2-4 hours, 4-5 hours, 5-8 hours, 8-11 hours and 11-24 hours
Change in urinary creatinine (mmol/l)
Time frame: Measured from samples collected at baseline and between 0-2 hours, 2-4 hours, 4-5 hours, 5-8 hours, 8-11 hours and 11-24 hours
Change in serum creatinine (mmol/l)
Time frame: Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink
Change in c reactive protein (in milligrams per litre (mg/l)
Time frame: Measured at baseline, 2 and 5 hours post-consumption of test drink
Change in blood pressure (in millimetres of mercury (mmHg))
Time frame: Measured at baseline, 1, 2, 3, 5, and 24-hours post-consumption of test drink
Change in arterial stiffness (Augmentation index measured in %, pulse wave velocity measured in meters per second (m/s))
Time frame: Measured at baseline, 1, 2, 3, 5, and 24-hours post-consumption of test drink
Change in oxidative damage (in percentage (%) of tail DNA)
Time frame: Measured at baseline, 1 and 2 hours post-consumption of test drink
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 12771324Jacob RA, Spinozzi GM, Simon VA, Kelley DS, Prior RL, Hess-Pierce B, Kader AA. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9. doi: 10.1093/jn/133.6.1826.
- Background: PubMed 29529161White SJ, Carran EL, Reynolds AN, Haszard JJ, Venn BJ. The effects of apples and apple juice on acute plasma uric acid concentration: a randomized controlled trial. Am J Clin Nutr. 2018 Feb 1;107(2):165-172. doi: 10.1093/ajcn/nqx059.
- Background: PubMed 24570273Lynn A, Mathew S, Moore CT, Russell J, Robinson E, Soumpasi V, Barker ME. Effect of a tart cherry juice supplement on arterial stiffness and inflammation in healthy adults: a randomised controlled trial. Plant Foods Hum Nutr. 2014 Jun;69(2):122-7. doi: 10.1007/s11130-014-0409-x.
- Background: PubMed 29862410Chai SC , Davis K , Wright RS , Kuczmarski MF , Zhang Z . Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. Food Funct. 2018 Jun 20;9(6):3185-3194. doi: 10.1039/c8fo00468d.
- BackgroundBell, P. G., Gaze, D. C., Davison, G. W., George, T. W., Scotter, M. J., & Howatson, G. (2014). Montmorency tart cherry (Prunus cerasus L.) concentrate lowers uric acid, independent of plasma cyanidin-3-O-glucosiderutinoside. Journal of Functional Foods, 11, 82-90.
- Individual participant dataSharing planned: Undecided
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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.
Tony Lynn, PhD principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart cherry juice and Water in people with Uric Acid and Cardiovascular Diseases, run by Sheffield Hallam University at 1 site in United Kingdom.
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 2 inclusion and 3 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 27 Jun 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 Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 serum urate (in millimoles per litre (mmol/l) (time frame: Measured at baseline, 1, 2, 3, 5 and 24 hours post-consumption of test drink). 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 NCT04960527, which also lists 5 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 27 Jun 2024.