Vitamin ATBSNCT05604248
Kinetics of Retinol and TBS Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their TBS and Those of Their Infants
A study testing Intervention in people with Vitamin A, run by Cheikh Anta Diop University, Senegal at 1 site in Senegal.
Trial summary
Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. Read more about this study
- Who is it for?
- Ages 9 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSenegal
- Study dates
- 1 Apr 2023to 8 Jul 2023
- 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 9 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For mothers: Willing to participate in the study and to give 4 blood and 4 milk samples during the whole duration of the study, Being aged 18-45 years, Not planning to travel during the study duration
- For children: Being aged 9-18 months, Being breastfed, Mother willing to authorize 2 bloods, Do not receive vitamin A supplements during the study
Who cannot join
- For mothers: Being pregnant, Consuming vitamin A and/or effector supplements, Smoke or drink alcohol during the study period
- For children: Have received a vitamin A supplement in the two months prior to the study
- All: Had fever or any obviously known or clinical diagnosed disease, malaria positive, severe anemia, severe acute malnutrition or severe obesity, being hemophiliac
Trial locations and contacts
1 site in 1 country.
Senegal1 site
Universite Cheikh Anta Diop
Dakar, 10700
Nicole Idohou-Dossou, Pr, 775691311 ext. 00221, nicole.dossou@ucad.edu.sn
Adama Diouf, Pr, 776459651 ext. 00221, adama.diouf@ucad.edu.sn
About this study
Official title: Kinetics of Retinol and Total Body Stores Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their Total Body Stores and Those of Their Infants
Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. In Senegal, the prevalence of VAD, although low among women of reproductive age, is quite worrying among children under 5 years old. In 2009, the fortification of refined oil with vitamin A was made mandatory in addition to the strategies already in place. The study of the impact of these strategies on the vitamin A status of women and children, showed relatively stable prevalences between 2010 and 2018. However, this study used plasma retinol concentration as an indicator. It is known that evaluation of vitamin A status is relatively insensitive when based on changes in plasma retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Incremental studies in the Dakar region using the modified relative dose response (MRDR) test in children under 2 years of age have indicated adequate vitamin A stores and a low prevalence of vitamin A deficiency in these children. The various strategies to prevent and control vitamin A deficiency have reportedly improved and even increased vitamin A stores in women and children, particularly in the Dakar region. Indeed, the latter benefit from substantial intakes of preformed retinol through the fortification program, and the majority of children under 2 years of age are breastfed.
The aim of this study is to use a more sensitive method than plasma retinol, the retinol isotope dilution (RID) test, to assess the actual status of subjects following these different strategies and to better orient the policies implemented in Senegal.
Read the detailed description
Specifics objectives are:
To determine transfer of tracer to breast milk To determine the composite coefficient (FaS) using mathematical modeling To estimate TBS using the generated coefficients and the RID equation among mothers To estimate TBS from breast milk retinol using the mass balance equation among mothers To estimate TBS from serum retinol using the mass balance equation among mothers and their children To assess the agreement between TBS measured by different methods (the RID equation, the mass balance equation using serum or breast-milk derived retinol) among mothers To evaluate the relationship between mothers' and children's TBS according to their status To assess dietary intakes of vitamin A among mother-child pairs
The study is designed following a "Wonder women model". It will be implemented in Dakar city. A total of fifty-six (56) lactating mother-child pairs will be included in the study. The women will be divided into 8 groups of 7 women each. This sample size includes an attrition rate of 15%.
At baseline (day 0), blood samples will be obtained from all the women after an overnight fast. Women will also be asked to give casual milk samples. Then, each woman will be given an oral dose of 2.0 μmol 13C2 -retinyl acetate (Gannon et al., 2014; Kaliwile et al., 2021). Afterward, participants will consume a peanut butter-based snack to provide fat to improve dose absorption. The women will also have a follow-up sample taken at day 14. As for baseline, a follow-up milk sample will be collected. Short-term sampling of both blood and milk will occur between days 0 and 14 and between days 14 and 109. In total, each woman will have 4 blood and 4 milk samples taken over time.
For infants, the RID test will start at day 14. After the baseline blood, they will receive 1.0 μmol 13C2-retinyl acetate and will have a second blood sample at day 28. Thus, infants will have 2 blood samples.
The protocol will be explained to the mother and written consent will be obtained from her. Lactating mother-infant pairs will be dewormed before starting the research protocol.
The blood samples will be protected from light with aluminum foil and centrifuged at 3500 rpm for 15 minutes to separate serum from clot. All centrifugations will be done in the hour following the blood sampling and using a centrifuge. The serum will be aliquoted into sterile cryogenic vials and stored at -80 °C at the laboratory.
Regarding milk samples, 2 aliquots will be prepared in 2 cryovials and stored at +4°C in the field and at -80°C at the laboratory.
An interviewer-administered questionnaire will allow collection of background information and dietary data from mother-infant pairs. Dietary intakes of mother-infant pairs will be assessed using 2 quantitative 24-hour dietary recalls on non-consecutive days (FAO, 2018). The Minimum Dietary Diversity for Women (MDD-W) will also be determined from the 24-hour dietary recalls. For children, Infant and Young Child Feeding practices indicators will be assessed following the latest WHO/UNICEF recommendations (WHO/UNICEF, 2021).
Anthropometric measurements will be performed to evaluate the nutritional status of mother-infant pairs according to standard procedures.
Sample analysis:
Serum Retinol concentration will be done by HPLC. Natural abundance of 13C in serum and milk will be measured by Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS). CRP and AGP will be measured by Biosystems A15 automatic analyzer. Retinyl esters and serum carotenoids will be done by Ultra-Performance Liquid Chromatography (UPLC).
Anemia will be assessed by measuring hemoglobin (Hb) in whole blood using a HemoCue system (Hb-301) and malaria testing will be performed using SD BIOLINE Malaria Antigen P.f/Pan1 tests.
Further analysis will be done on saliva samples in a subsample of mother-child pair to measure milk production by the mother-dose deuterium isotope dilution method. Deuterium enrichment of saliva samples will be measured with a Fourier transform infrared spectrometer (FTIR Shimadzu IR Affinity, Kyoto, Japan).
Modelling retinol kinetics among mothers :
Serum and breast milk retinol concentrations and isotope enrichment data will be used to generate super women data sets. Model-based compartmental analysis will be applied to super women isotope tracer data for serum and breast milk enrichment using established models for vitamin A metabolism (Green et al., 2020; Gannon et al., 2018) and expanding these models to incorporate tracer transfer to breast milk.
Determination of Fa and S factors:
Outputs from the model-based compartmental analysis include estimates for vitamin A transfer rates among physiologically-based compartments and the resulting model outcomes; total traced mass, half-life, fractional catabolic rate, disposal rate, equilibration time, and serum/body tracer partitioning (factor S). Using absorption assumptions, the amount of tracer dose absorbed and stored at the time of sampling (related to factor Fa and other related equation coefficients) will be determined.
TBS calculation:
Mass balance equation: The isotopic ratio of tracer to tracee (TTR) (unlabeled retinol) in serum will be used to estimate total body VA stores (TBS) using the following equation with appropriate assumptions:
TBS (μmol)= a × 1/TTR× (factors for correction of absorption and storage) a is the dose amount RID equation: TBS (μmol)= Fa × S × (1/〖SAp〗) Fa is the fraction of the oral tracer dose absorbed and retained in stores S is the ratio of the specific activity of retinol (labeled retinol/unlabeled retinol) in plasma to that in liver after dose equilibration SAp is the specific activity of retinol (labeled retinol/unlabeled retinol) in plasma.
For mothers, Fa and S will be calculated using mathematical modelling while SAp will be analytically determined. Among children, generic values for Fa and S will be used.
Statistical analysis:
Data entry and quality control will be performed using Epi infoTM 7.2.3.1, Epi infoTM 3.5.1 (Centers for Disease Control and Prevention) and Microsoft Excel 2016 (Microsoft Corporation). Statistical analysis will be performed using STATA/SE 14.0 (STATA Corporation). Descriptive analysis will be used to tabulate the characteristics of the study population. Categorical variables will be expressed as percentages, and continuous variables as mean ± SD for normally distributed variables and median with interquartile range for skewed values. Two-tailed Student's t- test, Paired t-test or one-way analysis of variance (ANOVA) followed by Bonferroni's post-hoc comparison tests will be used to compare means while the Wilcoxon rank-sum test will be used to compare medians. Pearson's chi-squared test, Fisher's exact test or McNemar's chi-square test will be used to compare percentages. Appropriate agreement tests will be performed. All the statistical analysis stages will be performed by an experienced statistician using appropriate methodology to ensure proper and reliable outcomes.
- Conditions
- Vitamin A
- Being tested
- Intervention
- Keywords
- Vitamin A status, Retinol isotope dilution technique, compartmental modeling, Wonder women, 13C2-Retinyl acetate, Senegal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Also called Stable isotope
Mother : 2.0 μmol 13C2 -retinyl acetate diluted in soybean oil Children : 1.0 μmol 13C2 -retinyl acetate diluted in soybean oil
| Study group | Role | What they receive |
|---|---|---|
| Lactating mother-infant pair | Other | 8 arms of 7 lactating women for a total of 56 women following a study design integrating a model-based compartmental analysis with the Retinol Isotope Dilution (RID) technique using a "Wonder women" approach.
For infants, the RID test will start at day 14. After the baseline blood, they will receive 1.0 μmol 13C2-retinyl acetate and will have a second blood sample at day 28. Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A status
Total body store vitamin A (µmol)
Measured: Within the coming 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Apr 2023 (estimated)
- Primary completion8 Apr 2023 (estimated)
- Study completion8 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin AStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheikh Anta Diop University, Senegal
- Sponsor type
- University, hospital or other
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Pernille Kaestel, PhD, Study director, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604248
- Sponsor's protocol ID
- E43035
- Acronym
- TBS
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2022
- Last updated
- 10 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Retinol and Total Body Stores Among Lactating Senegalese Women Living in an Urban Setting and the Relationship Between Their Total Body Stores and Those of Their Infants
- ClinicalTrials.gov ID
- NCT05604248
- Acronym / sponsor ID
- TBS / E43035
- Conditions
- Vitamin A
- Keywords
- Vitamin A status, Retinol isotope dilution technique, compartmental modeling, Wonder women, 13C2-Retinyl acetate, Senegal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cheikh Anta Diop University, SenegalUniversity, hospital or other
- Collaborators
- International Atomic Energy Agency
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 8 Apr 2023 (estimated)
- Study completion
- 8 Jul 2023 (estimated)
- First posted
- 3 Nov 2022 (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.
Vitamin A deficiency (VAD) is still a serious public health problem in most developing countries. Several strategies are used to prevent and address the consequences of this deficiency and to reduce its prevalence, particularly in Africa. In Senegal, the prevalence of VAD, although low among women of reproductive age, is quite worrying among children under 5 years old. In 2009, the fortification of refined oil with vitamin A was made mandatory in addition to the strategies already in place. The study of the impact of these strategies on the vitamin A status of women and children, showed relatively stable prevalences between 2010 and 2018. However, this study used plasma retinol concentration as an indicator. It is known that evaluation of vitamin A status is relatively insensitive when based on changes in plasma retinol concentrations, which are homeostatically controlled and negatively affected by subclinical infections. Incremental studies in the Dakar region using the modified relative dose response (MRDR) test in children under 2 years of age have indicated adequate vitamin A stores and a low prevalence of vitamin A deficiency in these children. The various strategies to prevent and control vitamin A deficiency have reportedly improved and even increased vitamin A stores in women and children, particularly in the Dakar region. Indeed, the latter benefit from substantial intakes of preformed retinol through the fortification program, and the majority of children under 2 years of age are breastfed.
The aim of this study is to use a more sensitive method than plasma retinol, the retinol isotope dilution (RID) test, to assess the actual status of subjects following these different strategies and to better orient the policies implemented in Senegal.
Detailed description
Specifics objectives are:
To determine transfer of tracer to breast milk To determine the composite coefficient (FaS) using mathematical modeling To estimate TBS using the generated coefficients and the RID equation among mothers To estimate TBS from breast milk retinol using the mass balance equation among mothers To estimate TBS from serum retinol using the mass balance equation among mothers and their children To assess the agreement between TBS measured by different methods (the RID equation, the mass balance equation using serum or breast-milk derived retinol) among mothers To evaluate the relationship between mothers' and children's TBS according to their status To assess dietary intakes of vitamin A among mother-child pairs
The study is designed following a "Wonder women model". It will be implemented in Dakar city. A total of fifty-six (56) lactating mother-child pairs will be included in the study. The women will be divided into 8 groups of 7 women each. This sample size includes an attrition rate of 15%.
At baseline (day 0), blood samples will be obtained from all the women after an overnight fast. Women will also be asked to give casual milk samples. Then, each woman will be given an oral dose of 2.0 μmol 13C2 -retinyl acetate (Gannon et al., 2014; Kaliwile et al., 2021). Afterward, participants will consume a peanut butter-based snack to provide fat to improve dose absorption. The women will also have a follow-up sample taken at day 14. As for baseline, a follow-up milk sample will be collected. Short-term sampling of both blood and milk will occur between days 0 and 14 and between days 14 and 109. In total, each woman will have 4 blood and 4 milk samples taken over time.
For infants, the RID test will start at day 14. After the baseline blood, they will receive 1.0 μmol 13C2-retinyl acetate and will have a second blood sample at day 28. Thus, infants will have 2 blood samples.
The protocol will be explained to the mother and written consent will be obtained from her. Lactating mother-infant pairs will be dewormed before starting the research protocol.
The blood samples will be protected from light with aluminum foil and centrifuged at 3500 rpm for 15 minutes to separate serum from clot. All centrifugations will be done in the hour following the blood sampling and using a centrifuge. The serum will be aliquoted into sterile cryogenic vials and stored at -80 °C at the laboratory.
Regarding milk samples, 2 aliquots will be prepared in 2 cryovials and stored at +4°C in the field and at -80°C at the laboratory.
An interviewer-administered questionnaire will allow collection of background information and dietary data from mother-infant pairs. Dietary intakes of mother-infant pairs will be assessed using 2 quantitative 24-hour dietary recalls on non-consecutive days (FAO, 2018). The Minimum Dietary Diversity for Women (MDD-W) will also be determined from the 24-hour dietary recalls. For children, Infant and Young Child Feeding practices indicators will be assessed following the latest WHO/UNICEF recommendations (WHO/UNICEF, 2021).
Anthropometric measurements will be performed to evaluate the nutritional status of mother-infant pairs according to standard procedures.
Sample analysis:
Serum Retinol concentration will be done by HPLC. Natural abundance of 13C in serum and milk will be measured by Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS). CRP and AGP will be measured by Biosystems A15 automatic analyzer. Retinyl esters and serum carotenoids will be done by Ultra-Performance Liquid Chromatography (UPLC).
Anemia will be assessed by measuring hemoglobin (Hb) in whole blood using a HemoCue system (Hb-301) and malaria testing will be performed using SD BIOLINE Malaria Antigen P.f/Pan1 tests.
Further analysis will be done on saliva samples in a subsample of mother-child pair to measure milk production by the mother-dose deuterium isotope dilution method. Deuterium enrichment of saliva samples will be measured with a Fourier transform infrared spectrometer (FTIR Shimadzu IR Affinity, Kyoto, Japan).
Modelling retinol kinetics among mothers :
Serum and breast milk retinol concentrations and isotope enrichment data will be used to generate super women data sets. Model-based compartmental analysis will be applied to super women isotope tracer data for serum and breast milk enrichment using established models for vitamin A metabolism (Green et al., 2020; Gannon et al., 2018) and expanding these models to incorporate tracer transfer to breast milk.
Determination of Fa and S factors:
Outputs from the model-based compartmental analysis include estimates for vitamin A transfer rates among physiologically-based compartments and the resulting model outcomes; total traced mass, half-life, fractional catabolic rate, disposal rate, equilibration time, and serum/body tracer partitioning (factor S). Using absorption assumptions, the amount of tracer dose absorbed and stored at the time of sampling (related to factor Fa and other related equation coefficients) will be determined.
TBS calculation:
Mass balance equation: The isotopic ratio of tracer to tracee (TTR) (unlabeled retinol) in serum will be used to estimate total body VA stores (TBS) using the following equation with appropriate assumptions:
TBS (μmol)= a × 1/TTR× (factors for correction of absorption and storage) a is the dose amount RID equation: TBS (μmol)= Fa × S × (1/〖SAp〗) Fa is the fraction of the oral tracer dose absorbed and retained in stores S is the ratio of the specific activity of retinol (labeled retinol/unlabeled retinol) in plasma to that in liver after dose equilibration SAp is the specific activity of retinol (labeled retinol/unlabeled retinol) in plasma.
For mothers, Fa and S will be calculated using mathematical modelling while SAp will be analytically determined. Among children, generic values for Fa and S will be used.
Statistical analysis:
Data entry and quality control will be performed using Epi infoTM 7.2.3.1, Epi infoTM 3.5.1 (Centers for Disease Control and Prevention) and Microsoft Excel 2016 (Microsoft Corporation). Statistical analysis will be performed using STATA/SE 14.0 (STATA Corporation). Descriptive analysis will be used to tabulate the characteristics of the study population. Categorical variables will be expressed as percentages, and continuous variables as mean ± SD for normally distributed variables and median with interquartile range for skewed values. Two-tailed Student's t- test, Paired t-test or one-way analysis of variance (ANOVA) followed by Bonferroni's post-hoc comparison tests will be used to compare means while the Wilcoxon rank-sum test will be used to compare medians. Pearson's chi-squared test, Fisher's exact test or McNemar's chi-square test will be used to compare percentages. Appropriate agreement tests will be performed. All the statistical analysis stages will be performed by an experienced statistician using appropriate methodology to ensure proper and reliable outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating mother-infant pair | Other | Other: Intervention8 arms of 7 lactating women for a total of 56 women following a study design integrating a model-based compartmental analysis with the Retinol Isotope Dilution (RID) technique using a "Wonder women" approach. For infants, the RID test will start at day 14. After the baseline blood, they will receive 1.0 μmol 13C2-retinyl acetate and will have a second blood sample at day 28. |
Who may qualify
- Ages
- 9 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- For mothers: Willing to participate in the study and to give 4 blood and 4 milk samples during the whole duration of the study, Being aged 18-45 years, Not planning to travel during the study duration
- For children: Being aged 9-18 months, Being breastfed, Mother willing to authorize 2 bloods, Do not receive vitamin A supplements during the study
Key exclusion criteria (3 listed)
- For mothers: Being pregnant, Consuming vitamin A and/or effector supplements, Smoke or drink alcohol during the study period
- For children: Have received a vitamin A supplement in the two months prior to the study
- All: Had fever or any obviously known or clinical diagnosed disease, malaria positive, severe anemia, severe acute malnutrition or severe obesity, being hemophiliac
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 |
|---|---|---|
| InterventionAlso: Stable isotopeMother : 2.0 μmol 13C2 -retinyl acetate diluted in soybean oil Children : 1.0 μmol 13C2 -retinyl acetate diluted in soybean oil | Other | Lactating mother-infant pair |
Primary outcome
Vitamin A status
Time frame: Within the coming 2 years
Total body store vitamin A (µmol)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- 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.
Pernille Kaestel, PhD study director
International Atomic Energy Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Vitamin A, run by Cheikh Anta Diop University, Senegal at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 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 Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Idohou-Dossou,, Pr (775691311 ext. 00221, nicole.dossou@ucad.edu.sn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin A status (time frame: Within the coming 2 years). 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 10 Nov 2022.