HypertensionPhase 2BBCNCT03070483
Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
A Phase 2 study testing Cholecalciferol in people with Hypertension and Vitamin D Deficiency, run by Loyola University at 1 site in United States.
Trial summary
Adequate levels of vitamin D are essential for bone health at all ages but low levels of vitamin D may also negatively impact other aspects of health such as blood pressure. The investigators have previously shown that adults with African ancestry living near the equator have much higher levels of vitamin D and higher… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2018to 1 Nov 2018
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-45 years
- Self-reported race/ethnicity African American
- BMI ≥ 18 kg/m2
- Total 25(OH)D levels < 20 ng/ml (50 nmol/L)
- No use of vitamin D supplements within past 30 days of the screening visit
- Able to provide written informed consent
Show all 10Show fewer
- Willing to take a vitamin D supplement daily for 3 months
- Willing to return for follow-up visits to measure blood pressure and provide a blood sample to measure vitamin D and serum calcium
- No current use of blood pressure lowering medications
- Systolic blood pressure ≥ 100 mmHg and diastolic blood pressure ≥ 60 mmHg
Who cannot join
- Medical history of chronic disease that affect gastrointestinal absorption of vitamin D: Crohn's disease, cystic fibrosis, and celiac disease
- Use of medications which may affect total 25(OH)D levels: antiepileptic drugs, steroids, bile acid sequestrants, lipase inhibitors, orlistat
- Current use of vitamin D supplements or use in past month and unwillingness to discontinue for at least 1 month prior to study enrollment
- History of kidney stones or hypercalciuria
- Fasting serum calcium ≥ 10.2 mg/dl
- Average systolic blood pressure ≥ 140 mmHg
Show all 10Show fewer
- Average diastolic blood pressure ≥ 90 mmHg
- Presence of type 1 diabetes mellitus, active malignancy, active thyroid disease or sarcoidosis
- Pregnant or planning a pregnancy
- Estimated glomerular filtration rate (based on serum creatinine level) is < 60 ml/min/1.73 m2 based on the Modification of Diet in Renal Disease formula
Trial locations and contacts
1 site in 1 country.
About this study
Adequate levels of vitamin D are essential for bone health at all ages but low levels of vitamin D may also negatively impact other aspects of health such as blood pressure. The investigators have previously shown that adults with African ancestry living near the equator have much higher levels of vitamin D and higher levels of blood pressure compared to adults with African ancestry living in the Chicago area. Multiple clinical trials have examined vitamin D supplementation for reducing blood pressure levels but very few studies have focused on adults with African ancestry and low vitamin D levels. In addition, most previous clinical trials have not addressed calcium intake. While vitamin D may modulate blood pressure via its actions on activation of the renin angiotensin aldosterone system, it is also possible that vitamin D mediates blood pressure via its effects on gastrointestinal calcium absorption. This pilot study is a one arm study, which will assess the safety and feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium daily for 3 months. Participants will be recruited from the Maywood Illinois and surrounding areas with flyers and brochures. The investigators will also contact previous participants of the Modeling the Epidemiologic Study/Vitamin D Ancillary Study by phone and letters. At baseline, all participants will have blood pressure measured and will provide a fasting serum specimen and a 24-hour urine collection. Calcium, parathyroid hormone level vitamin D will be measured in serum specimens and 24-hour urine calcium excretion will be measured. Repeat visits will be completed at 6 and 12 weeks of follow-up to again measure resting blood pressure and serum calcium and vitamin D levels. The overall goal is to collect pilot data to help design a larger trial of vitamin D and calcium supplementation for lowering blood pressure in young adults with African ancestry.
Read the detailed description
This pilot study will recruit 15 black U.S. adults ages 25-45 years of age with 25(OH)D levels < 20 ng/ml and no use of anti-hypertensive medications and a resting seated systolic blood pressure ≥ 120 mmHg and will measure baseline levels of total 25(OH)D, 25(OH)D2, 25(OH)D3, free vitamin 25(OH)D, active vitamin D [1,25(OH)D], parathyroid hormone level, serum calcium, and 24-hour calcium excretion.
Participants will then take the supplements vitamin D3 5000 IU and elemental calcium 1000 mg daily for three months. Investigators will measure changes in blood pressure, total 25(OH)D, 25(OH)D2 and 25(OH)D3, 1,25(OH)D and free 25(OH)D, parathyroid hormone levels, serum calcium and 24-hour urine calcium excretion over the three month period.
The overall goal is to collect pilot data to determine the feasibility of a larger trial to determine whether vitamin D combined with calcium lowers blood pressure in young black adults with low 25(OH)D levels.
This will be a single arm non-blinded feasibility study of 15 participants. The study population will consist of 15 adults ages 25-45 years with self-reported African American race/ethnicity. All participants will provide written informed consent.
Intervention:
This study has only one arm and all participants will receive Cholecalciferol (vitamin D3) 5,000 IU daily for 3 months and 1000 mg of calcium citrate daily for 3 months. There will be no placebo and no blinding of the agent. Participants will receive a 3 month supply of drugs which will be administered by the Loyola pharmacy. Serum vitamin D and calcium levels will be measured at study initiation and at 6 and 12 weeks (study end). Participants will stop taking stop both vitamin D and calcium administration with serum calcium levels are greater than or equal to 10.6 meq/L and/or a 25(OH)D levels are greater than or equal to 80 ng/dl at the 6 week visit.
Safety Monitoring:
The investigators will query any hospitalizations or emergency room visits over the past month and reasons for those visits at the baseline, 6 and 12 week follow-up visits. Serum calcium and vitamin D levels will be measured at 6 and 12 weeks and anyone with serum calcium levels ≥ 10.6 meq/L and/or a 25(OH)D level ≥ 80 ng/ml will stop treatment. All adverse events will be reported to the Loyola University Chicago Health Sciences Institutional Review Board. A data safety and monitoring board will review all data collected after completion of the 6 week visit to ensure safety of the study.
Stopping plans:
Any participant who develops a serum calcium levels ≥ 10.6 meq/L and/or a 25(OH)D level ≥ 80 ng/ml will stop treatment but they will continue to be monitored in the study through week 12 when serum calcium and 25(OH)D levels will be measured at the end of the study. The study will continue until participants have been followed for 12 weeks.
Analysis Plan:
This feasibility study will examine multiple aspects of the pilot data including the total number of persons enrolled vs. number of total persons identified as eligible. Pill counts will be done at the 6 and 12 week visit to assess compliance with vitamin D and calcium supplementation. The percentage of participants taking 80% or more of the vitamin D3 supplement and the calcium supplement will be determined. The number of participants reporting symptoms and all adverse events will be quantified. Repeated measures analysis of variance models will be used to assess change in the outcome measures including systolic and diastolic blood pressure, vitamin D measures, parathyroid hormone levels and 24-hour urine calcium excretion values.
- Conditions
- Hypertension, Vitamin D Deficiency
- Being tested
- Cholecalciferol
- Medical subject headings
- Hypertension, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
5000 IU cholecalciferol with 1000 mg calcium citrate daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Participants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Blood Pressure From Baseline to 12 Weeks
Seated blood pressure is measured at baseline and at 6 and 12 week follow-up visits in the clinic using an appropriate sized cuff after a rest period using an automated device (Omron). Blood pressure will be measured three times in one minute intervals at each time point and the average of these three recordings will be recorded as the mean blood pressure at each time point. Arm circumference will be measured to ensure the correct cuff size is used for all blood pressure measurements including home monitoring of blood pressure. Due to small number of participants, the change in mean blood pressure was analyzed as difference in mean blood pressure (2 x average diastolic blood pressure + average systolic blood pressure)/3 between baseline and at 12 weeks.
Measured: Difference in BP from baseline and 12 weeks after initiation of intervention
Secondary outcomes (5)
Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks
Total 25-hydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry
Measured: Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention
Change in Free 25-hydroxyvitamin D Levels From Baseline to 12 Weeks
Free 25(OH)D levels-will be measured using kits from Future Diagnostics (Wijchen, The Netherlands).
Measured: Baseline and at 12 weeks after initiation of intervention
Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks
Intact parathyroid hormone levels will be measured with the use of the Elecsys Parathyroid Hormone Immunoassay
Measured: Change in PTH levels from baseline and at 12 weeks after initiation of intervention
Change in 1,25-dihydroxyvitamin D From Baseline to 12 Weeks
1,25 -dihydroxyvitamin D will be measured with the use of liquid chromatography-tandem mass spectrometry
Measured: Change in 1,25 dihydroxyvitamin D levels from baseline and at 12 weeks after initiation of intervention
Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks
A 24-hour urine will be collected and calcium will be measured by Quest diagnostics
Measured: Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start25 Mar 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot study is a one arm study which will assess the safety and feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium daily for 3 months
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly J. Mattix-Kramer, Loyola University
- Investigators
- Holly Kramer, MD MPH, Principal investigator, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070483
- Sponsor's protocol ID
- 209476
- Acronym
- BBC
- Status last verified
- Apr 2020
- First submitted
- 20 Feb 2017
- Last updated
- 24 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiang D, Kramer H, Luke A, Cooper R, Aloia J, Bovet P, Plange-Rhule J, Forrester T, Lambert V, Camacho P, Dugas L, Durazo-Arvizu R. 25-Hydroxyvitamin D and blood pressure: a plateau effect in adults with African ancestry living at different latitudes. J Hypertens. 2017 May;35(5):968-974. doi: 10.1097/HJH.0000000000001263.
PubMed 28118279
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure in Blacks and Calcium (BBC) and Vitamin D Study
- ClinicalTrials.gov ID
- NCT03070483
- Acronym / sponsor ID
- BBC / 209476
- Conditions
- Hypertension, Vitamin D Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adequate levels of vitamin D are essential for bone health at all ages but low levels of vitamin D may also negatively impact other aspects of health such as blood pressure. The investigators have previously shown that adults with African ancestry living near the equator have much higher levels of vitamin D and higher levels of blood pressure compared to adults with African ancestry living in the Chicago area. Multiple clinical trials have examined vitamin D supplementation for reducing blood pressure levels but very few studies have focused on adults with African ancestry and low vitamin D levels. In addition, most previous clinical trials have not addressed calcium intake. While vitamin D may modulate blood pressure via its actions on activation of the renin angiotensin aldosterone system, it is also possible that vitamin D mediates blood pressure via its effects on gastrointestinal calcium absorption. This pilot study is a one arm study, which will assess the safety and feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium daily for 3 months. Participants will be recruited from the Maywood Illinois and surrounding areas with flyers and brochures. The investigators will also contact previous participants of the Modeling the Epidemiologic Study/Vitamin D Ancillary Study by phone and letters. At baseline, all participants will have blood pressure measured and will provide a fasting serum specimen and a 24-hour urine collection. Calcium, parathyroid hormone level vitamin D will be measured in serum specimens and 24-hour urine calcium excretion will be measured. Repeat visits will be completed at 6 and 12 weeks of follow-up to again measure resting blood pressure and serum calcium and vitamin D levels. The overall goal is to collect pilot data to help design a larger trial of vitamin D and calcium supplementation for lowering blood pressure in young adults with African ancestry.
Detailed description
This pilot study will recruit 15 black U.S. adults ages 25-45 years of age with 25(OH)D levels < 20 ng/ml and no use of anti-hypertensive medications and a resting seated systolic blood pressure ≥ 120 mmHg and will measure baseline levels of total 25(OH)D, 25(OH)D2, 25(OH)D3, free vitamin 25(OH)D, active vitamin D [1,25(OH)D], parathyroid hormone level, serum calcium, and 24-hour calcium excretion.
Participants will then take the supplements vitamin D3 5000 IU and elemental calcium 1000 mg daily for three months. Investigators will measure changes in blood pressure, total 25(OH)D, 25(OH)D2 and 25(OH)D3, 1,25(OH)D and free 25(OH)D, parathyroid hormone levels, serum calcium and 24-hour urine calcium excretion over the three month period.
The overall goal is to collect pilot data to determine the feasibility of a larger trial to determine whether vitamin D combined with calcium lowers blood pressure in young black adults with low 25(OH)D levels.
This will be a single arm non-blinded feasibility study of 15 participants. The study population will consist of 15 adults ages 25-45 years with self-reported African American race/ethnicity. All participants will provide written informed consent.
Intervention:
This study has only one arm and all participants will receive Cholecalciferol (vitamin D3) 5,000 IU daily for 3 months and 1000 mg of calcium citrate daily for 3 months. There will be no placebo and no blinding of the agent. Participants will receive a 3 month supply of drugs which will be administered by the Loyola pharmacy. Serum vitamin D and calcium levels will be measured at study initiation and at 6 and 12 weeks (study end). Participants will stop taking stop both vitamin D and calcium administration with serum calcium levels are greater than or equal to 10.6 meq/L and/or a 25(OH)D levels are greater than or equal to 80 ng/dl at the 6 week visit.
Safety Monitoring:
The investigators will query any hospitalizations or emergency room visits over the past month and reasons for those visits at the baseline, 6 and 12 week follow-up visits. Serum calcium and vitamin D levels will be measured at 6 and 12 weeks and anyone with serum calcium levels ≥ 10.6 meq/L and/or a 25(OH)D level ≥ 80 ng/ml will stop treatment. All adverse events will be reported to the Loyola University Chicago Health Sciences Institutional Review Board. A data safety and monitoring board will review all data collected after completion of the 6 week visit to ensure safety of the study.
Stopping plans:
Any participant who develops a serum calcium levels ≥ 10.6 meq/L and/or a 25(OH)D level ≥ 80 ng/ml will stop treatment but they will continue to be monitored in the study through week 12 when serum calcium and 25(OH)D levels will be measured at the end of the study. The study will continue until participants have been followed for 12 weeks.
Analysis Plan:
This feasibility study will examine multiple aspects of the pilot data including the total number of persons enrolled vs. number of total persons identified as eligible. Pill counts will be done at the 6 and 12 week visit to assess compliance with vitamin D and calcium supplementation. The percentage of participants taking 80% or more of the vitamin D3 supplement and the calcium supplement will be determined. The number of participants reporting symptoms and all adverse events will be quantified. Repeated measures analysis of variance models will be used to assess change in the outcome measures including systolic and diastolic blood pressure, vitamin D measures, parathyroid hormone levels and 24-hour urine calcium excretion values.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study is a one arm study which will assess the safety and feasibility of supplementing 15 young adults with African ancestry and low vitamin D levels with 5,000 IU of Cholecalciferol (vitamin D3) combined with 1000 mg of elemental calcium daily for 3 months
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: CholecalciferolParticipants will all receive supplementation with cholecalciferol 5000 IU and calcium citrate 1000 mg daily for 3 months |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 25-45 years
- Self-reported race/ethnicity African American
- BMI ≥ 18 kg/m2
- Total 25(OH)D levels < 20 ng/ml (50 nmol/L)
- No use of vitamin D supplements within past 30 days of the screening visit
Key exclusion criteria (10 listed)
- Medical history of chronic disease that affect gastrointestinal absorption of vitamin D: Crohn's disease, cystic fibrosis, and celiac disease
- Use of medications which may affect total 25(OH)D levels: antiepileptic drugs, steroids, bile acid sequestrants, lipase inhibitors, orlistat
- Current use of vitamin D supplements or use in past month and unwillingness to discontinue for at least 1 month prior to study enrollment
- History of kidney stones or hypercalciuria
- Fasting serum calcium ≥ 10.2 mg/dl
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 D35000 IU cholecalciferol with 1000 mg calcium citrate daily | Drug | Vitamin D |
Primary outcome
Change in Mean Blood Pressure From Baseline to 12 Weeks
Time frame: Difference in BP from baseline and 12 weeks after initiation of intervention
Seated blood pressure is measured at baseline and at 6 and 12 week follow-up visits in the clinic using an appropriate sized cuff after a rest period using an automated device (Omron). Blood pressure will be measured three times in one minute intervals at each time point and the average of these three recordings will be recorded as the mean blood pressure at each time point. Arm circumference will be measured to ensure the correct cuff size is used for all blood pressure measurements including home monitoring of blood pressure. Due to small number of participants, the change in mean blood pressure was analyzed as difference in mean blood pressure (2 x average diastolic blood pressure + average systolic blood pressure)/3 between baseline and at 12 weeks.
5 secondary outcomes
Change in Total 25-hydroxyvitamin D From Baseline to 12 Weeks
Time frame: Change in total 25-hydroxyvitamin D level from baseline to 12 weeks after initiation of intervention
Change in Free 25-hydroxyvitamin D Levels From Baseline to 12 Weeks
Time frame: Baseline and at 12 weeks after initiation of intervention
Change in Intact Parathyroid Hormone Levels From Baseline to 12 Weeks
Time frame: Change in PTH levels from baseline and at 12 weeks after initiation of intervention
Change in 1,25-dihydroxyvitamin D From Baseline to 12 Weeks
Time frame: Change in 1,25 dihydroxyvitamin D levels from baseline and at 12 weeks after initiation of intervention
Change in 24-hour Urine Calcium Excretion From Baseline to 12 Weeks
Time frame: Change in 24 hour urine calcium excretion from baseline and at 12 weeks after initiation of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28118279Chiang D, Kramer H, Luke A, Cooper R, Aloia J, Bovet P, Plange-Rhule J, Forrester T, Lambert V, Camacho P, Dugas L, Durazo-Arvizu R. 25-Hydroxyvitamin D and blood pressure: a plateau effect in adults with African ancestry living at different latitudes. J Hypertens. 2017 May;35(5):968-974. doi: 10.1097/HJH.0000000000001263.
- 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.
Holly Kramer, MD MPH principal investigator
Loyola University Chicago
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 Cholecalciferol in people with Hypertension and Vitamin D Deficiency, run by Loyola University 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 10 inclusion and 10 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 24 Jun 2020. 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. 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 24 Jun 2020). 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 Mean Blood Pressure From Baseline to 12 Weeks (time frame: Difference in BP from baseline and 12 weeks after initiation of intervention). 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 NCT03070483, which also lists 1 linked publication.
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 24 Jun 2020.