Iron-deficiencyNCT04194255
The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements
A study testing ferrous fumarate, ferrous fumarate + 15 g GOS and ferrous fumarate + 15 g FOS in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Iron deficiency (ID) remains the most common global nutrient deficiency, with young women at high risk. Iron supplements are first line treatment for ID but absorption is often low. Dietary components that could increase iron absorption would be valuable. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- ferrous fumarate, ferrous fumarate + 15 g GOS and ferrous fumarate + 15 g FOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jul 2020to 6 Oct 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, 18 to 45 years old
- SF concentrations ≤ 25 µg/L
- Normal body Mass Index (18.5-24.9 kg/m2)
- Body weight <70 kg
- Signed informed consent
Who cannot join
- Anaemia (Hb < 11,7g/dL)
- Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives),
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and/or probiotic supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Known difficulties with blood sampling
Show all 15Show fewer
- Use of antibiotics over the past month
- Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
- Women who are pregnant or breast feeding
- Women who intend to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse
- Smokers (> 1 cigarette per week)
- Inability to follow the procedures of the study, e.g. due to language problems, self-reported psychological disorders, etc. of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Single Dose Oral Galacto-oligosaccharides, Fructo-oligosaccharides and Acacia Gum on Iron Absorption From Single 100 mg Oral Iron Doses Given as Ferrous Fumarate in Women Living in Switzerland
Iron deficiency (ID) remains the most common global nutrient deficiency, with young women at high risk. Iron supplements are first line treatment for ID but absorption is often low. Dietary components that could increase iron absorption would be valuable.
Prebiotics are among the potential enhancers of non-heme iron absorption. Galacto-oligosaccharides (GOS), fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics.
Read more
To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%).
For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia. If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.
Read the detailed description
Prebiotics are defined as "microbial food supplements that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacterial species already resident in the colon". Moreover, prebiotics are potential enhancers of iron absorption, via several mechanisms: a) increasing gastric residence time allowing for greater iron dissolution; b) stimulating enterocyte gene expression of proteins involved in iron absorption; c) stimulating enterocyte proliferation providing a greater surface for iron absorption; and d) stimulating SCFA production by gut commensal bacteria, decreasing distal gut luminal pH and increasing iron dissolution.
Galacto-oligosaccharides (GOS), a safe and widely-used prebiotic, are a mixture of glucose- and galactose-based di- and oligosaccharides of varying structure and may be more selectively utilized by Bifidobacterium spp. than other prebiotics. Fructo-oligosaccharides (FOS) are composed by 4 to 9 units of fructose alone or in combination with one unit of glucose. FOS are widely used as food ingredients/nutritional supplements due to their bifidogenic properties. Acacia gum is composed by highly branched galactan polymers with galactose and/or arabinose side chains, possibly terminated by rhamnose or glucuronic acid residues. Both in-vitro and in-vivo studies have shown that acacia gum supports bifidobacterial growth and short-chain fatty acids (SCFA) production in the large intestine.
GOS and FOS have received GRAS status in the USA. Acacia gum is extensively used in the food industry for various functions (emulsification, encapsulation, stabilization, etc.). It is affirmed as "GRAS" for use in various food items. Acacia gum in human subjects is well tolerated up to 50 g/day. The European Food Safety Authority stated that there is no safety concern for the use of Acacia Gum as a food supplement.
To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. In humans, studies so far have failed in showing an effect of FOS on iron absorption. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. Moreover, in a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%). In another study in our lab (unpublished data) we found that 7 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+26%), in iron depleted women. These effects were found to be iron compound specific and could not be shown for ferrous sulfate, the iron compound used in the existing human studies with FOS.
For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia.
If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.
- Conditions
- Iron-deficiency
- Being tested
- ferrous fumarate, ferrous fumarate + 15 g GOS, ferrous fumarate + 15 g FOS, labelled iron as ferrous fumarate + 15 g acacia gum
- Keywords
- iron-deficiency, Prebiotics, galacto-oligosaccharides, fructo-oligosaccharides, acacia gum
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferrous fumarateDietary supplement
iron (100 mg) supplement in form of ferrous fumarate
ferrous fumarate + 15 g GOSDietary supplement
iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)
ferrous fumarate + 15 g FOSDietary supplement
iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g FOS)
labelled iron as ferrous fumarate + 15 g acacia gumDietary supplement
iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g acacia gum)
| Study group | Role | What they receive |
|---|---|---|
| ferrous fumarate | Experimental | labelled iron as ferrous fumarate Receives: Dietary Supplement: ferrous fumarate |
| ferrous fumarate + 15 g GOS | Experimental | labelled iron as ferrous fumarate + prebiotics in the form of 15 g GOS Receives: Dietary Supplement: ferrous fumarate + 15 g GOS |
| ferrous fumarate + 15 g FOS | Experimental | labelled iron as ferrous fumarate + prebiotics in the form of 15 g FOS Receives: Dietary Supplement: ferrous fumarate + 15 g FOS |
| ferrous fumarate + 15 g acacia gum | Experimental | labelled iron as ferrous fumarate + prebiotics in the form of 15 g acacia gum Receives: Dietary Supplement: labelled iron as ferrous fumarate + 15 g acacia gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
fractional iron absorption
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
Measured: 43 days
Secondary outcomes (7)
Hemoglobin (Hb)
Measured: Baseline, 43 days
Serum ferritin
Measured: Baseline, 43 days
soluble transferrin receptor
Measured: Baseline, 43 days
serum iron
Measured: Baseline, 43 days
alpha-1-acid glycoprotein (AGP)
Measured: Baseline, 43 days
C-reactive protein (CRP)
Measured: Baseline, 43 days
Retinol binding protein (RBP)
Measured: Baseline, 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start20 Jul 2020
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Herter-Aeberli, PhD, Study director, Laboratory of Human Nutrition ETH Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194255
- Sponsor's protocol ID
- HIGH
- Status last verified
- Jan 2021
- First submitted
- 9 Dec 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giorgetti A, Husmann FMD, Zeder C, Herter-Aeberli I, Zimmermann MB. Prebiotic Galacto-Oligosaccharides and Fructo-Oligosaccharides, but Not Acacia Gum, Increase Iron Absorption from a Single High-Dose Ferrous Fumarate Supplement in Iron-Depleted Women. J Nutr. 2022 Apr 1;152(4):1015-1021. doi: 10.1093/jn/nxac003.
PubMed 35015879
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Dose Oral Galacto-oligosaccharides, Fructo-oligosaccharides and Acacia Gum on Iron Absorption From Single 100 mg Oral Iron Doses Given as Ferrous Fumarate in Women Living in Switzerland
- ClinicalTrials.gov ID
- NCT04194255
- Acronym / sponsor ID
- HIGH
- Conditions
- Iron-deficiency
- Keywords
- iron-deficiency, Prebiotics, galacto-oligosaccharides, fructo-oligosaccharides, acacia gum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 11 Dec 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.
Iron deficiency (ID) remains the most common global nutrient deficiency, with young women at high risk. Iron supplements are first line treatment for ID but absorption is often low. Dietary components that could increase iron absorption would be valuable.
Prebiotics are among the potential enhancers of non-heme iron absorption. Galacto-oligosaccharides (GOS), fructo-oligosaccharides and acacia gum are safe and widely-used prebiotics.
To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. In a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%).
For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia. If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.
Detailed description
Prebiotics are defined as "microbial food supplements that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacterial species already resident in the colon". Moreover, prebiotics are potential enhancers of iron absorption, via several mechanisms: a) increasing gastric residence time allowing for greater iron dissolution; b) stimulating enterocyte gene expression of proteins involved in iron absorption; c) stimulating enterocyte proliferation providing a greater surface for iron absorption; and d) stimulating SCFA production by gut commensal bacteria, decreasing distal gut luminal pH and increasing iron dissolution.
Galacto-oligosaccharides (GOS), a safe and widely-used prebiotic, are a mixture of glucose- and galactose-based di- and oligosaccharides of varying structure and may be more selectively utilized by Bifidobacterium spp. than other prebiotics. Fructo-oligosaccharides (FOS) are composed by 4 to 9 units of fructose alone or in combination with one unit of glucose. FOS are widely used as food ingredients/nutritional supplements due to their bifidogenic properties. Acacia gum is composed by highly branched galactan polymers with galactose and/or arabinose side chains, possibly terminated by rhamnose or glucuronic acid residues. Both in-vitro and in-vivo studies have shown that acacia gum supports bifidobacterial growth and short-chain fatty acids (SCFA) production in the large intestine.
GOS and FOS have received GRAS status in the USA. Acacia gum is extensively used in the food industry for various functions (emulsification, encapsulation, stabilization, etc.). It is affirmed as "GRAS" for use in various food items. Acacia gum in human subjects is well tolerated up to 50 g/day. The European Food Safety Authority stated that there is no safety concern for the use of Acacia Gum as a food supplement.
To our knowledge, no studies have assessed the effect of acacia gum on iron absorption in human or animal models. Evidence exists about the enhancement of iron absorption when given in combination with FOS in rats. In humans, studies so far have failed in showing an effect of FOS on iron absorption. However, an iron stable isotope study in infants reported that 7.5 g of GOS improved iron absorption from 5 mg iron from a mixture of ferrous fumarate and sodium iron EDTA. Moreover, in a recent iron absorption study in adult women with low iron stores in our lab we found that 15 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+61%) and a meal (+28%). In another study in our lab (unpublished data) we found that 7 g of GOS given with FeFum (14 mg of elemental iron) acutely increased iron absorption when given with water (+26%), in iron depleted women. These effects were found to be iron compound specific and could not be shown for ferrous sulfate, the iron compound used in the existing human studies with FOS.
For prevention of anemia among non-pregnant women, the WHO recommends intermittent (once, twice or three times a week) oral iron supplementation with 60 mg of elemental iron. This has been shown to be effective, safe and acceptable for improving hemoglobin concentrations in women and lowering their risk of anemia.
If GOS improves iron absorption from a higher dose of iron, and if FOS and acacia gum might also enhance iron absorption from FeFum is unclear. With this study we therefore aim to investigate if consumption of a single oral dose of 15 g GOS, FOS or acacia gum increase iron absorption from single 100 mg oral iron doses, a common amount found in supplements on the market for treatment of iron deficiency, given as ferrous fumarate in otherwise healthy iron depleted women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ferrous fumarate | Experimental | Dietary Supplement: ferrous fumaratelabelled iron as ferrous fumarate |
| ferrous fumarate + 15 g GOS | Experimental | Dietary Supplement: ferrous fumarate + 15 g GOSlabelled iron as ferrous fumarate + prebiotics in the form of 15 g GOS |
| ferrous fumarate + 15 g FOS | Experimental | Dietary Supplement: ferrous fumarate + 15 g FOSlabelled iron as ferrous fumarate + prebiotics in the form of 15 g FOS |
| ferrous fumarate + 15 g acacia gum | Experimental | Dietary Supplement: labelled iron as ferrous fumarate + 15 g acacia gumlabelled iron as ferrous fumarate + prebiotics in the form of 15 g acacia gum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female, 18 to 45 years old
- SF concentrations ≤ 25 µg/L
- Normal body Mass Index (18.5-24.9 kg/m2)
- Body weight <70 kg
- Signed informed consent
Key exclusion criteria (15 listed)
- Anaemia (Hb < 11,7g/dL)
- Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole study (except for contraceptives),
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and/or probiotic supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
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 |
|---|---|---|
| ferrous fumarateiron (100 mg) supplement in form of ferrous fumarate | Dietary supplement | ferrous fumarate |
| ferrous fumarate + 15 g GOSiron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS) | Dietary supplement | ferrous fumarate + 15 g GOS |
| ferrous fumarate + 15 g FOSiron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g FOS) | Dietary supplement | ferrous fumarate + 15 g FOS |
| labelled iron as ferrous fumarate + 15 g acacia gumiron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g acacia gum) | Dietary supplement | ferrous fumarate + 15 g acacia gum |
Primary outcome
fractional iron absorption
Time frame: 43 days
Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
7 secondary outcomes
Hemoglobin (Hb)
Time frame: Baseline, 43 days
Serum ferritin
Time frame: Baseline, 43 days
soluble transferrin receptor
Time frame: Baseline, 43 days
serum iron
Time frame: Baseline, 43 days
alpha-1-acid glycoprotein (AGP)
Time frame: Baseline, 43 days
C-reactive protein (CRP)
Time frame: Baseline, 43 days
Retinol binding protein (RBP)
Time frame: Baseline, 43 days
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 22 Jan 2021.
- Derived from this study: PubMed 35015879Giorgetti A, Husmann FMD, Zeder C, Herter-Aeberli I, Zimmermann MB. Prebiotic Galacto-Oligosaccharides and Fructo-Oligosaccharides, but Not Acacia Gum, Increase Iron Absorption from a Single High-Dose Ferrous Fumarate Supplement in Iron-Depleted Women. J Nutr. 2022 Apr 1;152(4):1015-1021. doi: 10.1093/jn/nxac003.
- 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.
Isabelle Herter-Aeberli, PhD study director
Laboratory of Human Nutrition ETH Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ferrous fumarate, ferrous fumarate + 15 g GOS and ferrous fumarate + 15 g FOS in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 5 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 22 Jan 2021. 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 Switzerland. 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?
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?
fractional iron absorption (time frame: 43 days). 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 NCT04194255, 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 22 Jan 2021.