Iron Supplementation and Gastrointestinal HealthIN-FORMNCT07078630
Modulation of hepcidIN With Co-supplementation of Iron and FORMulated Curcumin in Recreational Athletes
A study testing HydroCurc® and Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron in people with Iron Supplementation and Gastrointestinal Health and Iron Deficiency, run by University of Westminster at 1 site in United Kingdom.
Trial summary
Iron deficiency and iron deficiency anaemia are common among endurance athletes partly due to a repeated post-exercise elevation of hepcidin, a hormone limiting iron entry through the intestine. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Supplementation and Gastrointestinal Health, Iron Deficiency
- What is being tested?
- HydroCurc® and Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2023to 24 Jan 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult (18-40 years) endurance male \& female runners.
- All participants will be accustomed to exercising at least 150 minutes per week, meeting the minimum NHS exercise recommendation.
- Participants will be fit enough to run for 60 minutes on a treadmill at 70% of their V̇O2max. To that end, participants will undergo a fitness test in the screening visit.
Who cannot join
- <18 years or >40 years
- Those with deficient/excess/abnormal iron levels according to UK guidelines \&/or haemochromatosis
- Any allergies/health issues related to items being ingested.
- Any illnesses or those on medication
- Those on iron or curcumin supplements
- Any pregnant or lactating women
Show all 16Show fewer
- Any women who are trying to conceive
- Any gastrointestinal disorders
- Any eating disorders
- Any abnormal blood pressure levels
- Consumption of >14 units of alcohol/week
- Devices such as pacemakers
- Smokers
- Renal disorders
- Dieters
- These criteria will be self-reported.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Westminster London
London, Greater London, W1W6UW
About this study
Official title: Co-supplementation of Ferrous Iron With Formulated Curcumin Reduces Hepcidin Response in Trained Individuals: a Cross-over, Double-blinded, Placebo-controlled Human Intervention Study
Iron deficiency and iron deficiency anaemia are common among endurance athletes partly due to a repeated post-exercise elevation of hepcidin, a hormone limiting iron entry through the intestine. Oral iron supplementation also causes stimulation of hepcidin that adds on to the exercise-intrinsic stimulation of this hormone further reducing iron absorption. Both oral ferrous iron therapy and performance running are known to cause undesired gastrointestinal symptoms. Curcumin, a polyphenol from turmeric, has been previously shown to reduce hepcidin levels in resting individuals and to protect the gastrointestinal (GI) function but its effect on active individuals supplementing with iron remains unclarified.
The objective of this research study is to learn about the effects of a formulated curcumin (HydroCurc®) on intestinal health and regulation mechanisms of body iron levels in recreationally active athletes supplementing with iron.
Read more
The main questions to answer are:
Does HydroCurc® influence iron regulatory mechanisms in resting conditions? Does HydroCurc® influence iron regulatory mechanisms in post-exercise conditions? Does HydroCurc® alleviate iron supplementation- and exercise-related gastrointestinal adverse events
Researchers will compare HydroCurc® to a placebo (a look-alike substance that contains no drug) to see if there are any significant changes.
Participants will:
- Perform a fitness test
- Take iron and HydroCurc for seven days
- Complete questionnaires on their gastrointestinal health
- Complete anthropometric testing
- Undergo blood sampling
Read the detailed description
Intervention study with two treatment groups in a randomised, double-blinded, placebo-controlled, crossover design.
Healthy recreationally active athletes will perform a VO2 max test to determine their aerobic capacity. A blood sample will be taken prior to the test as baseline measurement. Following treatment with iron plus either HydroCurc or a matched placebo for a week, participants will run on a treadmill for one hour at 70% of their maximal capacity. Blood samples will be collected before, immediately after, one hour post- and three hours post-exercise. Gastrointestinal symptoms will be assessed via validated questionnaires during the supplementation period and the experimental visits. All participants will observe a minimum of a two-week washout period. All participants will attend visits fasting for a minimum of four hours.
- Being tested
- Placebo, HydroCurc®, Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron
- Keywords
- Iron, Ferrous sulphate, Curcumin, IFABP, Ferritin, Interleukin-6, Hepcidin, Iron deficiency, Anaemia, Inflammation, Oxidative stress, Supplement, Gastrointestinal symptoms, Nutraceutical
- Medical subject headings
- Iron Deficiencies, Anemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Participants instructed to intake the placebo capsule along with the ferrous sulphate tablet, separated from food, tea or coffee, at the same time of the day.
HydroCurc®Dietary supplement
Participants instructed to intake the HydroCurc® capsule along with the ferrous sulphate tablet, separated from food, tea or coffee, at the same time of the day.
Ferrous sulphate 200mg oral tablet providing 65 mg of elemental ironDietary supplement
Participants instructed to intake the ferrous sulphate tablet along with the HydroCurc® or the placebo together, preferably and separated from food, tea or coffee, at the same time of the day.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous iron + placebo | Placebo comparator | * Dried ferrous sulphate tablet, 200mg providing 65 mg of elemental iron (Remedy Healthcare, UK).
* Placebo capsule containing maltodextrin and a food grade dye (yellow 5 or E102) (Fast Colours LLP, Huddersfield, UK) Receives: Dietary Supplement: Placebo; Dietary Supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron |
| Ferrous iron + HydroCurc | Active comparator | * Dried ferrous sulphate, 200mg tablet providing 65 mg of elemental iron (Remedy Healthcare, UK).
* HydroCurc (Gencor Pacific Limited, Lantau Island, Hong Kong), 500 mg capsule containing not less than 90% 115 curcuminoids (85% curcumin), formulated in 10% LipiSperse® (Pharmako Biotechnologies Pty Ltd, 116 Sydney, Australia), a delivery system comprising a proprietary mixture of surfactants, polar lipids 117 and solvents. Receives: Dietary Supplement: HydroCurc®; Dietary Supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions
Hepcidin, ng/mL
Measured: Hepcidin measured 1 day post supplementation
Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron
Hepcidin, ng/mL
Measured: Hepcidin measured 180 minutes post-exercise
Ferrous iron-associated iron status in athletes
Ferritin, ng/mL
Measured: Ferritin measured 1 day post supplementation
Change of exercise-associated inflammation in ferrous iron supplemented athletes
Interleukin-6, pg/mL
Measured: Interleukin-6 measured 0- and 60-minutes post-exercise
Secondary outcomes (3)
Exercise-associated intestinal damage in ferrous iron supplemented athletes
Intestinal Fatty Acid Binding Protein (IFABP), pg/mL
Measured: IFABP measured 0- and 60-minutes post-exercise
Incidence and frequency of ferrous iron associated-gastrointestinal symptoms
Subjective analysis via Oral Iron Supplement Questionnaire
Measured: Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days)
Number of participants supplementing with ferrous iron and reporting exercise-associated gastrointestinal symptoms
Subjective analysis via gastrointestinal symptom questionnaire
Measured: Gastrointestinal symptoms measured 30 minutes after the commencement of the exercise, 0-, 60- and 180- minutes post-exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start5 Oct 2023
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Iron Supplementation and Gastrointestinal HealthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomised, placebo-controlled, crossover.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Westminster
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmako Biotechnologies Pty Ltd
- Responsible party
- Principal investigator, Mohammed Gulrez Zariwala, University of Westminster
- Investigators
- Mohammed G Zariwala, PhD, Principal investigator, University of Westminster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078630
- Sponsor's protocol ID
- ETH2223-1363
- Acronym
- IN-FORM
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
PubMed 25700159Szymanski MC, Gillum TL, Gould LM, Morin DS, Kuennen MR. Short-term dietary curcumin supplementation reduces gastrointestinal barrier damage and physiological strain responses during exertional heat stress. J Appl Physiol (1985). 2018 Feb 1;124(2):330-340. doi: 10.1152/japplphysiol.00515.2017. Epub 2017 Sep 21.
PubMed 28935827Peters HP, Bos M, Seebregts L, Akkermans LM, van Berge Henegouwen GP, Bol E, Mosterd WL, de Vries WR. Gastrointestinal symptoms in long-distance runners, cyclists, and triathletes: prevalence, medication, and etiology. Am J Gastroenterol. 1999 Jun;94(6):1570-81. doi: 10.1111/j.1572-0241.1999.01147.x.
PubMed 10364027Ishibashi A, Maeda N, Kamei A, Goto K. Iron Supplementation during Three Consecutive Days of Endurance Training Augmented Hepcidin Levels. Nutrients. 2017 Jul 30;9(8):820. doi: 10.3390/nu9080820.
PubMed 28758951Laine F, Laviolle B, Bardou-Jacquet E, Fatih N, Jezequel C, Collet N, Ropert M, Morcet J, Hamon C, Reymann JM, Loreal O. Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study. Fundam Clin Pharmacol. 2017 Oct;31(5):567-573. doi: 10.1111/fcp.12288. Epub 2017 May 7.
PubMed 28370178Larsuphrom P, Latunde-Dada GO. Association of Serum Hepcidin Levels with Aerobic and Resistance Exercise: A Systematic Review. Nutrients. 2021 Jan 27;13(2):393. doi: 10.3390/nu13020393.
PubMed 33513924Keller K, Friedrich O, Treiber J, Quermann A, Friedmann-Bette B. Iron deficiency in athletes: Prevalence and impact on VO2 peak. Nutrition. 2024 Oct;126:112516. doi: 10.1016/j.nut.2024.112516. Epub 2024 Jun 10.
PubMed 39002373
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-supplementation of Ferrous Iron With Formulated Curcumin Reduces Hepcidin Response in Trained Individuals: a Cross-over, Double-blinded, Placebo-controlled Human Intervention Study
- ClinicalTrials.gov ID
- NCT07078630
- Acronym / sponsor ID
- IN-FORM / ETH2223-1363
- Keywords
- Iron, Ferrous sulphate, Curcumin, IFABP, Ferritin, Interleukin-6, Hepcidin, Iron deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WestminsterUniversity, hospital or other
- Collaborators
- Pharmako Biotechnologies Pty Ltd
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 22 Jul 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.
Iron deficiency and iron deficiency anaemia are common among endurance athletes partly due to a repeated post-exercise elevation of hepcidin, a hormone limiting iron entry through the intestine. Oral iron supplementation also causes stimulation of hepcidin that adds on to the exercise-intrinsic stimulation of this hormone further reducing iron absorption. Both oral ferrous iron therapy and performance running are known to cause undesired gastrointestinal symptoms. Curcumin, a polyphenol from turmeric, has been previously shown to reduce hepcidin levels in resting individuals and to protect the gastrointestinal (GI) function but its effect on active individuals supplementing with iron remains unclarified.
The objective of this research study is to learn about the effects of a formulated curcumin (HydroCurc®) on intestinal health and regulation mechanisms of body iron levels in recreationally active athletes supplementing with iron.
The main questions to answer are:
Does HydroCurc® influence iron regulatory mechanisms in resting conditions? Does HydroCurc® influence iron regulatory mechanisms in post-exercise conditions? Does HydroCurc® alleviate iron supplementation- and exercise-related gastrointestinal adverse events
Researchers will compare HydroCurc® to a placebo (a look-alike substance that contains no drug) to see if there are any significant changes.
Participants will:
- Perform a fitness test
- Take iron and HydroCurc for seven days
- Complete questionnaires on their gastrointestinal health
- Complete anthropometric testing
- Undergo blood sampling
Detailed description
Intervention study with two treatment groups in a randomised, double-blinded, placebo-controlled, crossover design.
Healthy recreationally active athletes will perform a VO2 max test to determine their aerobic capacity. A blood sample will be taken prior to the test as baseline measurement. Following treatment with iron plus either HydroCurc or a matched placebo for a week, participants will run on a treadmill for one hour at 70% of their maximal capacity. Blood samples will be collected before, immediately after, one hour post- and three hours post-exercise. Gastrointestinal symptoms will be assessed via validated questionnaires during the supplementation period and the experimental visits. All participants will observe a minimum of a two-week washout period. All participants will attend visits fasting for a minimum of four hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomised, placebo-controlled, crossover.
| Arm | Type | Receives |
|---|---|---|
| Ferrous iron + placebo | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron* Dried ferrous sulphate tablet, 200mg providing 65 mg of elemental iron (Remedy Healthcare, UK). * Placebo capsule containing maltodextrin and a food grade dye (yellow 5 or E102) (Fast Colours LLP, Huddersfield, UK) |
| Ferrous iron + HydroCurc | Active comparator | Dietary Supplement: HydroCurc®, Dietary Supplement: Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron* Dried ferrous sulphate, 200mg tablet providing 65 mg of elemental iron (Remedy Healthcare, UK). * HydroCurc (Gencor Pacific Limited, Lantau Island, Hong Kong), 500 mg capsule containing not less than 90% 115 curcuminoids (85% curcumin), formulated in 10% LipiSperse® (Pharmako Biotechnologies Pty Ltd, 116 Sydney, Australia), a delivery system comprising a proprietary mixture of surfactants, polar lipids 117 and solvents. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult (18-40 years) endurance male \& female runners.
- All participants will be accustomed to exercising at least 150 minutes per week, meeting the minimum NHS exercise recommendation.
- Participants will be fit enough to run for 60 minutes on a treadmill at 70% of their V̇O2max. To that end, participants will undergo a fitness test in the screening visit.
Key exclusion criteria (16 listed)
- <18 years or >40 years
- Those with deficient/excess/abnormal iron levels according to UK guidelines \&/or haemochromatosis
- Any allergies/health issues related to items being ingested.
- Any illnesses or those on medication
- Those on iron or curcumin supplements
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 |
|---|---|---|
| PlaceboParticipants instructed to intake the placebo capsule along with the ferrous sulphate tablet, separated from food, tea or coffee, at the same time of the day. | Dietary supplement | Ferrous iron + placebo |
| HydroCurc®Participants instructed to intake the HydroCurc® capsule along with the ferrous sulphate tablet, separated from food, tea or coffee, at the same time of the day. | Dietary supplement | Ferrous iron + HydroCurc |
| Ferrous sulphate 200mg oral tablet providing 65 mg of elemental ironParticipants instructed to intake the ferrous sulphate tablet along with the HydroCurc® or the placebo together, preferably and separated from food, tea or coffee, at the same time of the day. | Dietary supplement | Ferrous iron + HydroCurc, Ferrous iron + placebo |
Primary outcome
Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions
Time frame: Hepcidin measured 1 day post supplementation
Hepcidin, ng/mL
Exercise-associated hepcidin concentration in athletes supplementing with ferrous iron
Time frame: Hepcidin measured 180 minutes post-exercise
Hepcidin, ng/mL
Ferrous iron-associated iron status in athletes
Time frame: Ferritin measured 1 day post supplementation
Ferritin, ng/mL
Change of exercise-associated inflammation in ferrous iron supplemented athletes
Time frame: Interleukin-6 measured 0- and 60-minutes post-exercise
Interleukin-6, pg/mL
3 secondary outcomes
Exercise-associated intestinal damage in ferrous iron supplemented athletes
Time frame: IFABP measured 0- and 60-minutes post-exercise
Incidence and frequency of ferrous iron associated-gastrointestinal symptoms
Time frame: Gastrointestinal symptoms analysed daily throughout the supplementation period (seven continuous days)
Number of participants supplementing with ferrous iron and reporting exercise-associated gastrointestinal symptoms
Time frame: Gastrointestinal symptoms measured 30 minutes after the commencement of the exercise, 0-, 60- and 180- minutes post-exercise.
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 21 Aug 2025.
- Background: PubMed 25700159Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
- Background: PubMed 28935827Szymanski MC, Gillum TL, Gould LM, Morin DS, Kuennen MR. Short-term dietary curcumin supplementation reduces gastrointestinal barrier damage and physiological strain responses during exertional heat stress. J Appl Physiol (1985). 2018 Feb 1;124(2):330-340. doi: 10.1152/japplphysiol.00515.2017. Epub 2017 Sep 21.
- Background: PubMed 10364027Peters HP, Bos M, Seebregts L, Akkermans LM, van Berge Henegouwen GP, Bol E, Mosterd WL, de Vries WR. Gastrointestinal symptoms in long-distance runners, cyclists, and triathletes: prevalence, medication, and etiology. Am J Gastroenterol. 1999 Jun;94(6):1570-81. doi: 10.1111/j.1572-0241.1999.01147.x.
- Background: PubMed 28758951Ishibashi A, Maeda N, Kamei A, Goto K. Iron Supplementation during Three Consecutive Days of Endurance Training Augmented Hepcidin Levels. Nutrients. 2017 Jul 30;9(8):820. doi: 10.3390/nu9080820.
- Background: PubMed 28370178Laine F, Laviolle B, Bardou-Jacquet E, Fatih N, Jezequel C, Collet N, Ropert M, Morcet J, Hamon C, Reymann JM, Loreal O. Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study. Fundam Clin Pharmacol. 2017 Oct;31(5):567-573. doi: 10.1111/fcp.12288. Epub 2017 May 7.
- Background: PubMed 33513924Larsuphrom P, Latunde-Dada GO. Association of Serum Hepcidin Levels with Aerobic and Resistance Exercise: A Systematic Review. Nutrients. 2021 Jan 27;13(2):393. doi: 10.3390/nu13020393.
- Background: PubMed 39002373Keller K, Friedrich O, Treiber J, Quermann A, Friedmann-Bette B. Iron deficiency in athletes: Prevalence and impact on VO2 peak. Nutrition. 2024 Oct;126:112516. doi: 10.1016/j.nut.2024.112516. Epub 2024 Jun 10.
- Individual participant dataSharing planned: No
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.
Mohammed G Zariwala, PhD principal investigator
University of Westminster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HydroCurc® and Ferrous sulphate 200mg oral tablet providing 65 mg of elemental iron in people with Iron Supplementation and Gastrointestinal Health and Iron Deficiency, run by University of Westminster 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 3 inclusion and 16 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 21 Aug 2025. 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. 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.
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?
Concentration of iron absorption regulatory hormone in athletes supplementing with ferrous iron in resting conditions (time frame: Hepcidin measured 1 day post supplementation). The study lists 4 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 NCT07078630, which also lists 7 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 21 Aug 2025.