AsthmaVITDASNCT04117581
A Study to Investigate the Effect of Vitamin D3 Supplementation on Asthma Symptoms in Adults With Asthma (VITDAS)
A study testing Vitamin D3 in people with Asthma and Vitamin D Deficiency, run by University of Chester at 1 site in United Kingdom.
Trial summary
Asthma is a disease characterised by chronic inflammation of the airways leading to symptoms including periods of shortness of breath, wheezing and a tight chest due to airway narrowing in affected patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Vitamin D Deficiency, Nutritional Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 1 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females aged 18 years to 65 years
- Asthma diagnosed by a general practitioner
- Taking inhaled therapy to treat asthma that is required at least two times per week
Who cannot join
- Taking vitamin D supplements or supplements containing calcium
- History of asthma requiring treatment with intubation and mechanical ventilation within the past five years
- Require inhaled asthma therapy more than four times per day
- Respiratory tract infection within the past four weeks
- Suffering from chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency
- History of smoking within the past year or > 10 years total
- Been on a sun holiday within a month of taking part in the study or during the study. For the purpose of this study a sun holiday is defined as: spending one week or more in a hotter climate with the intention of sun-bathing
- Unable to communicate in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Daily 5000 IU Vitamin D Supplement for the Improvement of Lung Function and Asthma Control in Adults With Asthma: a Randomised Controlled Trial
Asthma is a disease characterised by chronic inflammation of the airways leading to symptoms including periods of shortness of breath, wheezing and a tight chest due to airway narrowing in affected patients. Current data show that one in 12 adults are currently receiving treatment for asthma in the United Kingdom (UK), with the UK having some of the highest rates in Europe. In the winter, 30-40% of the UK population are vitamin D deficient with some asthma patients having significantly lower vitamin D levels compared to normal patients. Vitamin D has been shown to be involved in the development of immune-related disorders including asthma. Cross-sectional research has shown that reduced vitamin D levels are associated with reduced lung function, increased airway hyper-responsiveness and reduced response to glucocorticoids, suggesting vitamin D levels may also implicate asthma treatment. To date, there have been three randomised controlled trials (RCT) assessing the effect of vitamin D supplementation in adults with symptomatic asthma. These trials have not found a significant effect of vitamin D supplementation on asthma. However, these studies relied on high doses of vitamin D with long time periods between doses. There is a requirement for RCTs in adults with daily supplementation of lower doses of vitamin D as it has been suggested that daily supplementation is more effective for inducing non-classical actions of vitamin D. However, vitamin D has been found to significantly improve airway function as measured by forced expiratory volume in one second (FEV1) in adults supplemented with 100, 000 international units (IU) vitamin D intramuscularly plus 50, 000 IU oral vitamin D weekly. Therefore, the effect of daily dosing on lung function also requires investigation. Furthermore, these trials have focussed on clinical outcomes without investigating the cellular mechanisms affording protection.
Read the detailed description
Recruitment and sampling strategy:
Participants will be recruited from the University of Chester (staff and students) and surrounding areas, United Kingdom (UK) only. Emails, posters and social media will be used to advertise the study to the target group (adults with asthma). A total of 28 adults with asthma aged 18-65 years old will be included in the study based on criteria described below. Eligibility will be based upon previous diagnosis of asthma by a general practitioner (GP) and the number of times asthma medication is required at screening before the start of the study. Participants will be required to complete a screening questionnaire which will provide information about participant's health status, drugs/medication/supplement usage and sun exposure. Those that have had asthma diagnosed by a GP and require their medication more than twice per week will be included. All eligible participants will be briefed on the study protocol before the beginning of the study, and the eligible participants will be given a participant information sheet (PIS) and asked to provide written informed consent.
A 12 week, double blind, randomised controlled trial will be carried out in the clinical laboratory at The University of Chester, UK. Most vitamin D and asthma studies have used supplement concentrations up to 120, 000 international units (IU) with no adverse effects. The European Food Standards Agency (EFSA) set a no-observed-adverse-effect-level (NOAEL) of 10,000IU/day (COT, 2015).
Participants will be randomly allocated to 2 groups:
- vitamin D group
- placebo group
Participants assigned to the vitamin D group will consume one capsule containing 5000 IU vitamin D every day. Participants in the placebo group will take an identical capsule containing inert filler. Participants will be asked to maintain their dietary habits and physical activity. The remaining supplements will be returned at the final clinic (week 12) and compliance will be estimated.
Participants will be required to attend three clinics in total over a period of 12 weeks, and they will be assessed at baseline (Day 0), interim (Week 6) and post-intervention (Week 12). At each clinic, a 30ml blood sample will be taken and both height and weight will be measured. Before the start and end of the study, participants will be required to keep a 3-day food diary which includes two weekdays and one weekend day to represent the habitual dietary intake of the participants. At each clinic, participants will complete spirometry to measure forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) to assess lung function and complete the Asthma Control Test™ (ACT) to assess asthma symptoms. Blood samples will be analysed on collection for a total blood cell count. Blood samples will be centrifuged to remove plasma. Plasma samples will be batch analysed at the end of the intervention to assess biomarkers of vitamin D metabolism and inflammation.
Sample size and justification:
Sample size was estimated using vitamin D supplementation data from a study in which FEV1 post intervention at 6 months (mean ± standard deviation (S.D)) of 51.6 ± 9.4 L (vitamin D treatment group) and 31.9 ± 7.6 L (placebo group) was reported in chronic obstructive pulmonary disease patients receiving 100, 000 IU vitamin D each month. With an effect size of 1.8493555, the total sample size required for each group in the proposed study is 9. Taking into account a 20% drop out rate, and this study lasting only 12 weeks, the total sample size required is 14 (power = 0.9). Therefore, the total sample size needed for the whole study is 28. Sample size was estimated using G Power Software.
Statistical Analysis:
All statistical analyses will be conducted with the International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) Statistic Data Editor Software (version 25). Assuming the data is normally distributed after performing a Shapiro Wilks normality test, a mixed model analysis of variance (ANOVA) with t-test post-hoc analysis will be conducted to compare the mean differences for all measured parameters between the groups at the different time points. A non-parametric approach will be adopted if the data is not normally distributed for all analyses. Differences will be considered significant with a p value ≤ 0.05.
- Conditions
- Asthma, Vitamin D Deficiency, Nutritional Deficiency, Inflammation
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D, Asthma, Lung function, Inflammation
- Medical subject headings
- Asthma, Vitamin D Deficiency, Malnutrition, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
5000 IU (125 μg) vitamin D3 capsules daily over 12 weeks (84 days)
PlaceboOther
Also called Non active ingredient
Inert filler capsules daily over 12 weeks (84 days)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplement | Active comparator | Participant will be asked to take one capsule of vitamin D3 supplement (5000 IU) (125 μg) daily for a total duration of 12 weeks. Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Participants will be asked to take one capsule of placebo (inert filler) daily for a total duration of 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung function from baseline to 12 weeks
Forced expiratory volume in one second (FEV1) and forced expiratory volume (FVC) measured by spirometry
Measured: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes (11)
Change in Asthma Control Test™ score
Indication of level of asthma control according to participant. Score between 0 and 25.
Scores indicate:
25: Asthma appears to have been under control over the last 4 weeks 20 - 24: Asthma appears to have been reasonably well controlled over the last 4 weeks Less than 20: Asthma may not have been controlled during the past 4 weeks
Measured: 0 weeks, 6 weeks, 12 weeks
Change in vitamin D concentration from baseline to 12 weeks
Vitamin D3 status measured in plasma samples by enzyme-linked immunosorbent assay (ELISA) commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in parathyroid hormone (PTH) concentration from baseline to 12 weeks
Vitamin D metabolism biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in Full Blood Count Concentration from baseline to 12 weeks
Percentage granulocytes measured in whole blood samples by Beckman Coulter haematological analyser
Measured: 0 weeks, 6 weeks, 12 weeks
Change in interferon-gamma (IFN-ϒ) concentration from baseline to 12 weeks
Inflammatory biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in tumour-necrosis-factor-alpha (TNF-α) concentration from baseline to 12 weeks
Inflammatory biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in C-reactive protein (CRP) concentration from baseline to 12 weeks
Inflammatory biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in immunoglobulin E (IgE) concentration from baseline to 12 weeks
Antibody measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in interleukin-(IL)4 concentration from baseline to 12 weeks
Inflammatory biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in IL-10 concentration from baseline to 12 weeks
Inflammatory biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Change in IL-13 concentration from baseline to 12 weeks
Inflammatory biomarker measured in plasma samples by ELISA commercial kit
Measured: 0 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start28 Oct 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sohail Mushtaq, PhD, Principal investigator, University of Chester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117581
- Sponsor's protocol ID
- 1583/19/SW/CSN
- Acronym
- VITDAS
- Status last verified
- Feb 2022
- First submitted
- 4 Oct 2019
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Daily 5000 IU Vitamin D Supplement for the Improvement of Lung Function and Asthma Control in Adults With Asthma: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04117581
- Acronym / sponsor ID
- VITDAS / 1583/19/SW/CSN
- Conditions
- Asthma, Vitamin D Deficiency, Nutritional Deficiency, Inflammation
- Keywords
- Vitamin D, Asthma, Lung function, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ChesterUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 7 Oct 2019 (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.
Asthma is a disease characterised by chronic inflammation of the airways leading to symptoms including periods of shortness of breath, wheezing and a tight chest due to airway narrowing in affected patients. Current data show that one in 12 adults are currently receiving treatment for asthma in the United Kingdom (UK), with the UK having some of the highest rates in Europe. In the winter, 30-40% of the UK population are vitamin D deficient with some asthma patients having significantly lower vitamin D levels compared to normal patients. Vitamin D has been shown to be involved in the development of immune-related disorders including asthma. Cross-sectional research has shown that reduced vitamin D levels are associated with reduced lung function, increased airway hyper-responsiveness and reduced response to glucocorticoids, suggesting vitamin D levels may also implicate asthma treatment. To date, there have been three randomised controlled trials (RCT) assessing the effect of vitamin D supplementation in adults with symptomatic asthma. These trials have not found a significant effect of vitamin D supplementation on asthma. However, these studies relied on high doses of vitamin D with long time periods between doses. There is a requirement for RCTs in adults with daily supplementation of lower doses of vitamin D as it has been suggested that daily supplementation is more effective for inducing non-classical actions of vitamin D. However, vitamin D has been found to significantly improve airway function as measured by forced expiratory volume in one second (FEV1) in adults supplemented with 100, 000 international units (IU) vitamin D intramuscularly plus 50, 000 IU oral vitamin D weekly. Therefore, the effect of daily dosing on lung function also requires investigation. Furthermore, these trials have focussed on clinical outcomes without investigating the cellular mechanisms affording protection.
Detailed description
Recruitment and sampling strategy:
Participants will be recruited from the University of Chester (staff and students) and surrounding areas, United Kingdom (UK) only. Emails, posters and social media will be used to advertise the study to the target group (adults with asthma). A total of 28 adults with asthma aged 18-65 years old will be included in the study based on criteria described below. Eligibility will be based upon previous diagnosis of asthma by a general practitioner (GP) and the number of times asthma medication is required at screening before the start of the study. Participants will be required to complete a screening questionnaire which will provide information about participant's health status, drugs/medication/supplement usage and sun exposure. Those that have had asthma diagnosed by a GP and require their medication more than twice per week will be included. All eligible participants will be briefed on the study protocol before the beginning of the study, and the eligible participants will be given a participant information sheet (PIS) and asked to provide written informed consent.
A 12 week, double blind, randomised controlled trial will be carried out in the clinical laboratory at The University of Chester, UK. Most vitamin D and asthma studies have used supplement concentrations up to 120, 000 international units (IU) with no adverse effects. The European Food Standards Agency (EFSA) set a no-observed-adverse-effect-level (NOAEL) of 10,000IU/day (COT, 2015).
Participants will be randomly allocated to 2 groups:
- vitamin D group
- placebo group
Participants assigned to the vitamin D group will consume one capsule containing 5000 IU vitamin D every day. Participants in the placebo group will take an identical capsule containing inert filler. Participants will be asked to maintain their dietary habits and physical activity. The remaining supplements will be returned at the final clinic (week 12) and compliance will be estimated.
Participants will be required to attend three clinics in total over a period of 12 weeks, and they will be assessed at baseline (Day 0), interim (Week 6) and post-intervention (Week 12). At each clinic, a 30ml blood sample will be taken and both height and weight will be measured. Before the start and end of the study, participants will be required to keep a 3-day food diary which includes two weekdays and one weekend day to represent the habitual dietary intake of the participants. At each clinic, participants will complete spirometry to measure forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) to assess lung function and complete the Asthma Control Test™ (ACT) to assess asthma symptoms. Blood samples will be analysed on collection for a total blood cell count. Blood samples will be centrifuged to remove plasma. Plasma samples will be batch analysed at the end of the intervention to assess biomarkers of vitamin D metabolism and inflammation.
Sample size and justification:
Sample size was estimated using vitamin D supplementation data from a study in which FEV1 post intervention at 6 months (mean ± standard deviation (S.D)) of 51.6 ± 9.4 L (vitamin D treatment group) and 31.9 ± 7.6 L (placebo group) was reported in chronic obstructive pulmonary disease patients receiving 100, 000 IU vitamin D each month. With an effect size of 1.8493555, the total sample size required for each group in the proposed study is 9. Taking into account a 20% drop out rate, and this study lasting only 12 weeks, the total sample size required is 14 (power = 0.9). Therefore, the total sample size needed for the whole study is 28. Sample size was estimated using G Power Software.
Statistical Analysis:
All statistical analyses will be conducted with the International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) Statistic Data Editor Software (version 25). Assuming the data is normally distributed after performing a Shapiro Wilks normality test, a mixed model analysis of variance (ANOVA) with t-test post-hoc analysis will be conducted to compare the mean differences for all measured parameters between the groups at the different time points. A non-parametric approach will be adopted if the data is not normally distributed for all analyses. Differences will be considered significant with a p value ≤ 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplement | Active comparator | Dietary Supplement: Vitamin D3Participant will be asked to take one capsule of vitamin D3 supplement (5000 IU) (125 μg) daily for a total duration of 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be asked to take one capsule of placebo (inert filler) daily for a total duration of 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged 18 years to 65 years
- Asthma diagnosed by a general practitioner
- Taking inhaled therapy to treat asthma that is required at least two times per week
Key exclusion criteria (8 listed)
- Taking vitamin D supplements or supplements containing calcium
- History of asthma requiring treatment with intubation and mechanical ventilation within the past five years
- Require inhaled asthma therapy more than four times per day
- Respiratory tract infection within the past four weeks
- Suffering from chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency
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 |
|---|---|---|
| Vitamin D3Also: Cholecalciferol5000 IU (125 μg) vitamin D3 capsules daily over 12 weeks (84 days) | Dietary supplement | Vitamin D3 supplement |
| PlaceboAlso: Non active ingredientInert filler capsules daily over 12 weeks (84 days) | Other | Placebo |
Primary outcome
Change in lung function from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Forced expiratory volume in one second (FEV1) and forced expiratory volume (FVC) measured by spirometry
11 secondary outcomes
Change in Asthma Control Test™ score
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in vitamin D concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in parathyroid hormone (PTH) concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in Full Blood Count Concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in interferon-gamma (IFN-ϒ) concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in tumour-necrosis-factor-alpha (TNF-α) concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in C-reactive protein (CRP) concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in immunoglobulin E (IgE) concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in interleukin-(IL)4 concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in IL-10 concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
Change in IL-13 concentration from baseline to 12 weeks
Time frame: 0 weeks, 6 weeks, 12 weeks
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 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Sohail Mushtaq, PhD principal investigator
University of Chester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Asthma and Vitamin D Deficiency, run by University of Chester 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 8 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 4 Nov 2022. 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?
Change in lung function from baseline to 12 weeks (time frame: 0 weeks, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.