Graves' DiseaseDAGMARNCT02384668
D-vitamin And Graves' Disease; Morbidity And Relapse Reduction
A study testing Cholecalciferol in people with Graves' Disease, run by University of Aarhus at 8 sites in Denmark.
Trial summary
The purpose of this study is to investigate the effects of vitamin D supplementation on morbidity and risk of relapse in patients with Graves' disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 8 sitesDenmark
- Study dates
- 24 Mar 2015to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A first time diagnosis of Graves' hyperthyroidism within the last three months, confirmed by TSH below 0.01 IU/L, and T3 or T4 levels above the reference interval necessitating ATD therapy
- Positive TRAb
- Speak and read Danish
- Written informed consent
Who cannot join
- Previously diagnosed hyperthyroidism
- ATD treatment initiated more than 3 months prior to inclusion
- Planned ablative therapy (radioactive iodine or thyroid surgery)
- Intake of more than 10 µg D-vitamin/day that the participant wishes to continue.
- Chronic granulomatous illness
- Persistent hypercalcemia (plasma calcium > 1.40 mmol/L)
Show all 15Show fewer
- Reduced kidney function (eGFR < 45 ml/min)
- Treatment with immunomodulatory drugs
- Active malignant disease
- Alcohol or drug abuse
- Pregnancy at inclusion
- Major comorbidity, making the participant unlikely to continuously receive trial intervention.
- Allergy towards the components in the D-vitamin or the placebo pills.
- Unable to read and understand Danish
- Lack of informed consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus C, 8000
Gentofte Hospital
Gentofte Municipality, 2900
Department of Internal Medicine, Regionshospitalet Herning
Herning, 7400
Department of Internal Medicine, Regionshospitalet Holstebro
Holstebro, 7500
Department of Internal Medicine, Regionshospitalet Horsens
Horsens, 8700
Department of Internal Medicine, Regionhospitalet Randers
Randers, 8930
Department of Internal Medicine, Diagnostisk Center, Regionshospitalet Silkeborg
Silkeborg, 8600
Department of Internal Medicine, Regionshospitalet Viborg
Viborg, 8800
About this study
Official title: The DAGMAR Study. D-vitamin And Graves' Disease; Morbidity And Relapse Reduction: A Randomised, Clinical Trial.
The purpose of this study is to investigate the effects of vitamin D supplementation on morbidity and risk of relapse in patients with Graves' disease.
Read the detailed description
In a multicentre trial, 260 patients with newly diagnosed Graves ' disease will be randomized to cholecalciferol 70 mcg/day or placebo in a parallel Group design. Drop outs prior to 31th of December 2017 will be replaced. The intervention will continue during treatment with antithyroid drugs (ATD), and for a period of 12 months after cessation of ATD. Blood samples will be collected at study entry, at 3 and 9 months, and at end of study. QoL questionnaires on nine occasions through out the study period. In a subcohort of 80 participants detailed examinations of bone density and geometry, muscle strength and postural balance, immune tests (N=50), and measurements of arterial stiffness will be performed at study entry, and at 3 and 9 months after randomisation.
- Conditions
- Graves' Disease
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Cholecalciferol, Vitamin D3, Arterial stiffness, Quality of Life, Bone density and geometry, Muscle strength and balance
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called Vitamin D3
One tablet per day. The duration of the intervention period is between 24-36 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18(-24) months after randomisation. Vitamin D supplementation will continue 12 months after withdrawal of ATD treatment or until relapse of Graves' Disease if this occurs prior.
PlaceboDietary supplement
One tablet per day. Placebo tablet identical in appearance to cholecalciferol tablet. Duration and cessation of treatment identical to intervention with cholecalciferol.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | Cholecalciferol 70 mcg per day Other name: Vitamin D3. Receives: Dietary Supplement: Cholecalciferol |
| Placebo | Placebo comparator | Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
The placebo regimen is identical to the vitamin D3 regimen. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants without relapse within the first year after cessation of ATD treatment.
A relapse is defined as:
The participant has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period; or The participant has hyperthyroidism (TSH<0.1) at 12 months (+/- 1 months) after cessation of ATD treatment; or ATD is re-initiated within 12 months after cessation of initial ATD treatment; or The participant fails to stop ATD treatment within 24 months after initiation of ATD treatment.
Measured: 0-12 months after cessation of ATD treatment
Secondary outcomes (16)
The proportion of participants who has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period.
The proportion of participants who has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period.
Measured: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
The proportion of participants who have relapse of hyperthyroidism (TSH<0.1) after cessation of ATD therapy
The proportion of participants who have relapse of hyperthyroidism (TSH<0.1) after cessation of ATD therapy
Measured: 0-12 months after cessation of ATD treatment
The proportion of participants who re-initiates ATD treatment or is referred to radioactive iodine or thyroid surgery due to hyperthyroidism within 12 months after cessation of initial ATD treatment.
The proportion of participants who re-initiates ATD treatment or is referred to radioactive iodine or thyroid surgery due to hyperthyroidism within 12 months after cessation of initial ATD treatment.
Measured: 0-12 months after cessation of ATD treatment
The proportion of participants who fails to stop ATD treatment within 24 months after initiation of ATD therapy.
In a pre-planned sub-analysis participants on sustained ATD treatment for more than 24 months after initiation of ATD therapy because of Graves' orbitopathy will be excluded
Measured: 0-24 months after initiation of ATD therapy
Effects of D-vitamin supplementation according to plasma level of D-vitamin at inclusion to the study.
Sub analysis of all primary and secondary outcome measures will be performed according to this criteria.
Measured: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
Proportion of participants without relapse within the first year after cessation of ATD treatment according to baseline use of D-vitamin.
Sub analysis of baseline "users" versus "non-users" of D-vitamin supplementation with regards to effects of intervention on all primary and secondary outcome measures.
Measured: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 6 weeks
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 3 months
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 6 months
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 9 months
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 12 months
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 18 months
Quality of Life as measured by Health questionnaires
Thyroid specific QoL as measured by the global score in the thyPRO questionnaire.
Hyperthyroid symptoms (thyPRO subscale) Proportion of patients with eye symptoms (thyPRO subscale)
Measured: 24 months
Biomarkers of calcium- and bone metabolism.
Effects of intervention on biochemical markers of calcium and bone metabolism, such as calcium, phosphate, parathyroid hormone, calcitriol, vitamin D-binding protein, bone-specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen (P1NP). Also C-terminal telopeptide of type 1 collagen (CTX) and N-telopeptide of type 1 collagen (NTX) among others.
Measured: 3 months, 9 months and 12 months after cessation of ATD treatment, an expected average of 24 months
Level of Thyrotropin receptor antibody (TRAb)
Level of TRAb at 3 and 9 months and at end of study period (maximum of 36 months)
Measured: 3 months, 9 months and 12 months after cessation of ATD treatment, an expected average of 24 months
Level of 25 hydroxy vitamin D
Level of 25 hydroxy vitamin D at 3 and 9 months and at end of study period (maximum of 36 months)
Measured: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start24 Mar 2015
- Primary completionDec 2020
- Study completionDec 2020
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 Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Regional Hospital Holstebro, Regionshospitalet Horsens, Randers Regional Hospital, Regionshospitalet Viborg, Skive, Herning Hospital
- Responsible party
- Sponsor
- Investigators
- Lars Rejnmark, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384668
- Sponsor's protocol ID
- 12122012
- Acronym
- DAGMAR
- Status last verified
- Aug 2022
- First submitted
- 9 Jan 2015
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Grove-Laugesen D, Ebbehoj E, Watt T, Hansen KW, Rejnmark L. Changes in bone density and microarchitecture following treatment of Graves' disease and the effects of vitamin D supplementation. A randomized clinical trial. Osteoporos Int. 2024 Dec;35(12):2153-2164. doi: 10.1007/s00198-024-07241-y. Epub 2024 Sep 12.
PubMed 39264438Grove-Laugesen D, Ebbehoj E, Watt T, Riis AL, Ostergard T, Bruun BJ, Juel Christiansen J, Hansen KW, Rejnmark L. Effect of Vitamin D Supplementation on Graves' Disease: The DAGMAR Trial. Thyroid. 2023 Sep;33(9):1110-1118. doi: 10.1089/thy.2023.0111. Epub 2023 Jun 26.
PubMed 37218433Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
PubMed 35018442Grove-Laugesen D, Cramon PK, Malmstroem S, Ebbehoj E, Watt T, Hansen KW, Rejnmark L. Effects of Supplemental Vitamin D on Muscle Performance and Quality of Life in Graves' Disease: A Randomized Clinical Trial. Thyroid. 2020 May;30(5):661-671. doi: 10.1089/thy.2019.0634. Epub 2020 Feb 7.
PubMed 31910101Grove-Laugesen D, Malmstroem S, Ebbehoj E, Riis AL, Watt T, Hansen KW, Rejnmark L. Effect of 9 months of vitamin D supplementation on arterial stiffness and blood pressure in Graves' disease: a randomized clinical trial. Endocrine. 2019 Nov;66(2):386-397. doi: 10.1007/s12020-019-01997-8. Epub 2019 Jul 6.
PubMed 31280470
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DAGMAR Study. D-vitamin And Graves' Disease; Morbidity And Relapse Reduction: A Randomised, Clinical Trial.
- ClinicalTrials.gov ID
- NCT02384668
- Acronym / sponsor ID
- DAGMAR / 12122012
- Conditions
- Graves' Disease
- Keywords
- Cholecalciferol, Vitamin D3, Arterial stiffness, Quality of Life, Bone density and geometry, Muscle strength and balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg, Regional Hospital Holstebro, Regionshospitalet Horsens, Randers Regional Hospital, Regionshospitalet Viborg, Skive, Herning Hospital
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 10 Mar 2015 (estimated)
- 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 purpose of this study is to investigate the effects of vitamin D supplementation on morbidity and risk of relapse in patients with Graves' disease.
Detailed description
In a multicentre trial, 260 patients with newly diagnosed Graves ' disease will be randomized to cholecalciferol 70 mcg/day or placebo in a parallel Group design. Drop outs prior to 31th of December 2017 will be replaced. The intervention will continue during treatment with antithyroid drugs (ATD), and for a period of 12 months after cessation of ATD. Blood samples will be collected at study entry, at 3 and 9 months, and at end of study. QoL questionnaires on nine occasions through out the study period. In a subcohort of 80 participants detailed examinations of bone density and geometry, muscle strength and postural balance, immune tests (N=50), and measurements of arterial stiffness will be performed at study entry, and at 3 and 9 months after randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Active comparator | Dietary Supplement: CholecalciferolCholecalciferol 70 mcg per day Other name: Vitamin D3. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo tablets are identical in regards to size and appearance to the experimental intervention tablet. The placebo regimen is identical to the vitamin D3 regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A first time diagnosis of Graves' hyperthyroidism within the last three months, confirmed by TSH below 0.01 IU/L, and T3 or T4 levels above the reference interval necessitating ATD therapy
- Positive TRAb
- Speak and read Danish
- Written informed consent
Key exclusion criteria (15 listed)
- Previously diagnosed hyperthyroidism
- ATD treatment initiated more than 3 months prior to inclusion
- Planned ablative therapy (radioactive iodine or thyroid surgery)
- Intake of more than 10 µg D-vitamin/day that the participant wishes to continue.
- Chronic granulomatous illness
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D3One tablet per day. The duration of the intervention period is between 24-36 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18(-24) months after randomisation. Vitamin D supplementation will continue 12 months after withdrawal of ATD treatment or until relapse of Graves' Disease if this occurs prior. | Dietary supplement | Cholecalciferol |
| PlaceboOne tablet per day. Placebo tablet identical in appearance to cholecalciferol tablet. Duration and cessation of treatment identical to intervention with cholecalciferol. | Dietary supplement | Placebo |
Primary outcome
Proportion of participants without relapse within the first year after cessation of ATD treatment.
Time frame: 0-12 months after cessation of ATD treatment
A relapse is defined as: The participant has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period; or The participant has hyperthyroidism (TSH<0.1) at 12 months (+/- 1 months) after cessation of ATD treatment; or ATD is re-initiated within 12 months after cessation of initial ATD treatment; or The participant fails to stop ATD treatment within 24 months after initiation of ATD treatment.
16 secondary outcomes
The proportion of participants who has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period.
Time frame: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
The proportion of participants who have relapse of hyperthyroidism (TSH<0.1) after cessation of ATD therapy
Time frame: 0-12 months after cessation of ATD treatment
The proportion of participants who re-initiates ATD treatment or is referred to radioactive iodine or thyroid surgery due to hyperthyroidism within 12 months after cessation of initial ATD treatment.
Time frame: 0-12 months after cessation of ATD treatment
The proportion of participants who fails to stop ATD treatment within 24 months after initiation of ATD therapy.
Time frame: 0-24 months after initiation of ATD therapy
Effects of D-vitamin supplementation according to plasma level of D-vitamin at inclusion to the study.
Time frame: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
Proportion of participants without relapse within the first year after cessation of ATD treatment according to baseline use of D-vitamin.
Time frame: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
Quality of Life as measured by Health questionnaires
Time frame: 6 weeks
Quality of Life as measured by Health questionnaires
Time frame: 3 months
Quality of Life as measured by Health questionnaires
Time frame: 6 months
Quality of Life as measured by Health questionnaires
Time frame: 9 months
Quality of Life as measured by Health questionnaires
Time frame: 12 months
Quality of Life as measured by Health questionnaires
Time frame: 18 months
Quality of Life as measured by Health questionnaires
Time frame: 24 months
Biomarkers of calcium- and bone metabolism.
Time frame: 3 months, 9 months and 12 months after cessation of ATD treatment, an expected average of 24 months
Level of Thyrotropin receptor antibody (TRAb)
Time frame: 3 months, 9 months and 12 months after cessation of ATD treatment, an expected average of 24 months
Level of 25 hydroxy vitamin D
Time frame: From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months
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 1 Sep 2022.
- Derived from this study: PubMed 39264438Grove-Laugesen D, Ebbehoj E, Watt T, Hansen KW, Rejnmark L. Changes in bone density and microarchitecture following treatment of Graves' disease and the effects of vitamin D supplementation. A randomized clinical trial. Osteoporos Int. 2024 Dec;35(12):2153-2164. doi: 10.1007/s00198-024-07241-y. Epub 2024 Sep 12.
- Derived from this study: PubMed 37218433Grove-Laugesen D, Ebbehoj E, Watt T, Riis AL, Ostergard T, Bruun BJ, Juel Christiansen J, Hansen KW, Rejnmark L. Effect of Vitamin D Supplementation on Graves' Disease: The DAGMAR Trial. Thyroid. 2023 Sep;33(9):1110-1118. doi: 10.1089/thy.2023.0111. Epub 2023 Jun 26.
- Derived from this study: PubMed 35018442Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
- Derived from this study: PubMed 31910101Grove-Laugesen D, Cramon PK, Malmstroem S, Ebbehoj E, Watt T, Hansen KW, Rejnmark L. Effects of Supplemental Vitamin D on Muscle Performance and Quality of Life in Graves' Disease: A Randomized Clinical Trial. Thyroid. 2020 May;30(5):661-671. doi: 10.1089/thy.2019.0634. Epub 2020 Feb 7.
- Derived from this study: PubMed 31280470Grove-Laugesen D, Malmstroem S, Ebbehoj E, Riis AL, Watt T, Hansen KW, Rejnmark L. Effect of 9 months of vitamin D supplementation on arterial stiffness and blood pressure in Graves' disease: a randomized clinical trial. Endocrine. 2019 Nov;66(2):386-397. doi: 10.1007/s12020-019-01997-8. Epub 2019 Jul 6.
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Graves' Disease
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.
Lars Rejnmark, Professor principal investigator
Aarhus University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Graves' Disease, run by University of Aarhus at 8 sites in Denmark.
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 4 inclusion and 15 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. 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?
Proportion of participants without relapse within the first year after cessation of ATD treatment. (time frame: 0-12 months after cessation of ATD treatment). 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 NCT02384668, 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 1 Sep 2022.