Iron-deficiencyNCT03572010
Stable Iron Isotope Method in HIV+ and HIV- Children
A study testing FeFum fortified maize test meal, FeSO4 fortified LNS and FeSO4 supplement in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in South Africa.
Trial summary
The objective of this study is to compare HIV infected children to uninfected children regarding 1) quantifying iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements, and 2) quantifying the daily iron requirement. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- FeFum fortified maize test meal, FeSO4 fortified LNS and FeSO4 supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Africa
- Study dates
- 27 Sep 2018to 30 Jun 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 8-13 years at baseline
- Hemoglobin >=8 g/dL
- BMI -3 to 3 SD of reference population
- HIV criteria: soluble cluster of differentiation 4 (sCD4) >=500 cells/mm^3, HIV RNA viral load <50 copies/mL (measured as part of routine care)
- Plasma ferritin <30 mikrogramm/L
- The caregiver is willing to participate in the study
Show all 12Show fewer
- The caregiver speaks English, Afrikaans or isiXhosa
- The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) plus assent needs to be obtained from the child
- Residence in the study site for the period of the study.
- For non-iron deficient children:
- Hemoglobin >=11.5 g/dL
- Plasma ferritin >=40 mikrogramm/L
Who cannot join
- Iron supplements 3 months prior to study start
- Food allergy or intolerance against peanuts or milk
- Acute illness or other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Participants taking part in other studies requiring the drawing of blood
- Not planning long-term residence in study site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Stable Iron Isotope Method to Define Iron Needs and Improve Iron Nutrition in HIV+ and HIV- Children
The objective of this study is to compare HIV infected children to uninfected children regarding 1) quantifying iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements, and 2) quantifying the daily iron requirement.
Read the detailed description
In Sub-Saharan Africa, HIV is a major cause of morbidity and mortality in children. Anemia frequently complicates pediatric HIV infection and predicts disease progression and mortality. Iron requirements and the specific contribution of iron deficiency (ID) to anemia in pediatric HIV infection remains uncertain. The fundamental barrier to understanding iron nutrition in HIV infection is that sub-clinical inflammation in individuals with HIV infection confounds the usual bio-markers used to assess iron status and response to iron interventions. A novel iron stable isotope technique developed by ETH Zurich, Switzerland, is a promising new tool for better understanding of iron metabolism in HIV infection. In contrast to existing conventional bio-markers of iron status, a method based on isotopic dilution of whole body iron labeled with stable, non-radioactive isotopes of iron (58Fe, 57Fe) could directly quantify iron requirements, as well as iron absorption from interventions, completely free of bias and confounding by inflammation. This method could offer, for the first time, a long-term quantitative measure of iron balance and absorption from iron interventions and provide reliable data on which to base nutrition recommendations for HIV infection.
The objective is to compare HIV infected children to uninfected children: 1) Quantify iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements; 2) Quantify the daily iron requirement.
The study participants will be recruited from the South African Stellenbosch University/Tygerberg Children's Hospital long-term antiretroviral therapy (ART) cohort of perinatally HIV infected children and uninfected controls from the same communities, matched by age and gender. As a secondary outcome, we want to investigate the effect of iron supplementation on the gut microbiome.
In study 1, using a randomized cross-over design and stable isotope labeled single meal/doses the investigators will: a) quantify the impairment of dietary iron absorption in HIV infected, iron deficient children compared to HIV uninfected, iron deficient controls using a labeled iron fortified maize meal, a lipid-based nutritional supplement (LNS) and an oral iron supplement; and b) administer sufficient iron isotope label (57Fe) to allow equilibration and follow up of isotopic composition in the blood for two years (isotope dilution technique). At the end of Study 1, all iron deficient children will be iron replete prior to entering Study 2. In study 1, in parallel, a group of HIV infected and uninfected, iron sufficient children will be given orally 12 mg 57Fe as ferrous sulfate (FeSO4).
In study 2, the investigators will apply the principle of long-term isotope dilution to quantify the daily iron requirement in both the HIV infected and uninfected children, and the difference in iron requirements.
The overall goal is to provide optimized recommendations on dietary iron requirements and iron treatment regimens in HIV infected children, in order to reduce ID and anemia, improve their health and well-being, their long-term prognosis and quality of life.
- Conditions
- Iron-deficiency
- Being tested
- FeFum fortified maize test meal, FeSO4 fortified LNS, FeSO4 supplement, FeSO4 fortified fruit juice
- 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.
FeFum fortified maize test mealDietary supplement
Maize porridge extrinsically labeled with 2 mg ferrous fumarate (58FeFum); only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); cereal staple foods, like maize, depending on milling, may be high in phytic acid, a potent iron absorption inhibitor
FeSO4 fortified LNSDietary supplement
self-made Lipid-based nutritional supplement (LNS) extrinsically fortified and labeled with 6 mg ferrous sulfate (57FeSO4); only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); LNS may be a better food matrix for iron supplementation compared to maize-based porridge; contains canola oil, peanut paste, milk powder, sugar, maltodextrin and palm stearin
FeSO4 supplementDietary supplement
170 mg iron tablets as FeSO4 (containing 55 mg of elemental iron) with 6 mg extrinsically labeled 57Fe; will be given together with a glass of water; only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L);
FeSO4 fortified fruit juiceDietary supplement
Fruit juice labeled with 12 mg 57Fe as FeSO4; in the group for iron sufficient children
| Study group | Role | What they receive |
|---|---|---|
| FeFum fortified maize test meal | Placebo comparator | Not described Receives: Dietary Supplement: FeFum fortified maize test meal |
| FeSO4 fortified LNS | Placebo comparator | Not described Receives: Dietary Supplement: FeSO4 fortified LNS |
| FeSO4 supplement | Placebo comparator | Not described Receives: Dietary Supplement: FeSO4 supplement |
| FeSO4 fortified fruit juice | Placebo comparator | Not described Receives: Dietary Supplement: FeSO4 fortified fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption
Iron absorption will be measured from the 3 different types of iron vehicles from the iron deficient group (FeFum fortified maize porridge, FeSO4 containing LNS, FeSO4 supplement). It is estimated that iron absorption is lower in HIV infected children.
Measured: Measured 14 days after consumption of the 3 different types of iron vehicles (Days 17 and 31); Enrichment shift of iron isotopes into red blood cells from Day 31 to 451
Secondary outcomes (12)
Hemoglobin in g/dL (in blood)
to identify anemia
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Plasma ferritin in µg/L (in blood)
to identify iron deficiency
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Soluble transferrin receptor in mg/L (in blood)
to identify iron deficiency
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Transferrin saturation in % (in blood)
to calculate percent of transferrin that has iron bound to it; Plasma iron and transferrin saturation will be combined to calculate transferrin saturation (ratio)
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Erythropoetin (in blood)
produced in kidney and triggers production of red blood cells
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
C-reactive protein in mg/L (in blood)
to identify acute inflammation, which inhibits iron absorption
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
alpha-1-glycoprotein in g/L (in blood)
to identify chronic inflammation, which inhibits iron absorption
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Plasma hepcidin (in blood)
one of major iron absorption regulators
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Interleukin-6 (in blood)
systemic inflammation marker
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Intestinal fatty acid binding protein 1 and 2 (in blood)
inflammation marker for gut integrity
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Lipopolysaccharide binding protein (in blood)
immune response marker
Measured: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Fecal calprotectin (in stool)
gut inflammation marker
Measured: Days -1, 31 and 121 (in iron deficient children)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start27 Sep 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Stellenbosch
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572010
- Sponsor's protocol ID
- Fe_HIV
- Status last verified
- Sep 2021
- First submitted
- 16 May 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goosen C, Proost S, Baumgartner J, Mallick K, Tito RY, Barnabas SL, Cotton MF, Zimmermann MB, Raes J, Blaauw R. Associations of HIV and iron status with gut microbiota composition, gut inflammation and gut integrity in South African school-age children: a two-way factorial case-control study. J Hum Nutr Diet. 2023 Jun;36(3):819-832. doi: 10.1111/jhn.13171. Epub 2023 Apr 16.
PubMed 36992541Goosen C, Proost S, Tito RY, Baumgartner J, Barnabas SL, Cotton MF, Zimmermann MB, Raes J, Blaauw R. The effect of oral iron supplementation on the gut microbiota, gut inflammation, and iron status in iron-depleted South African school-age children with virally suppressed HIV and without HIV. Eur J Nutr. 2022 Jun;61(4):2067-2078. doi: 10.1007/s00394-021-02793-9. Epub 2022 Jan 8.
PubMed 34997267Goosen C, Baumgartner J, Mikulic N, Barnabas SL, Cotton MF, Zimmermann MB, Blaauw R. Examining Associations of HIV and Iron Status with Nutritional and Inflammatory Status, Anemia, and Dietary Intake in South African Schoolchildren. Nutrients. 2021 Mar 16;13(3):962. doi: 10.3390/nu13030962.
PubMed 33809705
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Stable Iron Isotope Method to Define Iron Needs and Improve Iron Nutrition in HIV+ and HIV- Children
- ClinicalTrials.gov ID
- NCT03572010
- Acronym / sponsor ID
- Fe_HIV
- Conditions
- Iron-deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Stellenbosch
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Jun 2018 (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.
The objective of this study is to compare HIV infected children to uninfected children regarding 1) quantifying iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements, and 2) quantifying the daily iron requirement.
Detailed description
In Sub-Saharan Africa, HIV is a major cause of morbidity and mortality in children. Anemia frequently complicates pediatric HIV infection and predicts disease progression and mortality. Iron requirements and the specific contribution of iron deficiency (ID) to anemia in pediatric HIV infection remains uncertain. The fundamental barrier to understanding iron nutrition in HIV infection is that sub-clinical inflammation in individuals with HIV infection confounds the usual bio-markers used to assess iron status and response to iron interventions. A novel iron stable isotope technique developed by ETH Zurich, Switzerland, is a promising new tool for better understanding of iron metabolism in HIV infection. In contrast to existing conventional bio-markers of iron status, a method based on isotopic dilution of whole body iron labeled with stable, non-radioactive isotopes of iron (58Fe, 57Fe) could directly quantify iron requirements, as well as iron absorption from interventions, completely free of bias and confounding by inflammation. This method could offer, for the first time, a long-term quantitative measure of iron balance and absorption from iron interventions and provide reliable data on which to base nutrition recommendations for HIV infection.
The objective is to compare HIV infected children to uninfected children: 1) Quantify iron absorption from iron fortified maize porridge, lipid-based food supplements and oral iron supplements; 2) Quantify the daily iron requirement.
The study participants will be recruited from the South African Stellenbosch University/Tygerberg Children's Hospital long-term antiretroviral therapy (ART) cohort of perinatally HIV infected children and uninfected controls from the same communities, matched by age and gender. As a secondary outcome, we want to investigate the effect of iron supplementation on the gut microbiome.
In study 1, using a randomized cross-over design and stable isotope labeled single meal/doses the investigators will: a) quantify the impairment of dietary iron absorption in HIV infected, iron deficient children compared to HIV uninfected, iron deficient controls using a labeled iron fortified maize meal, a lipid-based nutritional supplement (LNS) and an oral iron supplement; and b) administer sufficient iron isotope label (57Fe) to allow equilibration and follow up of isotopic composition in the blood for two years (isotope dilution technique). At the end of Study 1, all iron deficient children will be iron replete prior to entering Study 2. In study 1, in parallel, a group of HIV infected and uninfected, iron sufficient children will be given orally 12 mg 57Fe as ferrous sulfate (FeSO4).
In study 2, the investigators will apply the principle of long-term isotope dilution to quantify the daily iron requirement in both the HIV infected and uninfected children, and the difference in iron requirements.
The overall goal is to provide optimized recommendations on dietary iron requirements and iron treatment regimens in HIV infected children, in order to reduce ID and anemia, improve their health and well-being, their long-term prognosis and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FeFum fortified maize test meal | Placebo comparator | Dietary Supplement: FeFum fortified maize test meal |
| FeSO4 fortified LNS | Placebo comparator | Dietary Supplement: FeSO4 fortified LNS |
| FeSO4 supplement | Placebo comparator | Dietary Supplement: FeSO4 supplement |
| FeSO4 fortified fruit juice | Placebo comparator | Dietary Supplement: FeSO4 fortified fruit juice |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Age 8-13 years at baseline
- Hemoglobin >=8 g/dL
- BMI -3 to 3 SD of reference population
- HIV criteria: soluble cluster of differentiation 4 (sCD4) >=500 cells/mm^3, HIV RNA viral load <50 copies/mL (measured as part of routine care)
- Plasma ferritin <30 mikrogramm/L
Key exclusion criteria (5 listed)
- Iron supplements 3 months prior to study start
- Food allergy or intolerance against peanuts or milk
- Acute illness or other conditions that in the opinion of the PI or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
- Participants taking part in other studies requiring the drawing of blood
- Not planning long-term residence in study site.
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 |
|---|---|---|
| FeFum fortified maize test mealMaize porridge extrinsically labeled with 2 mg ferrous fumarate (58FeFum); only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); cereal staple foods, like maize, depending on milling, may be high in phytic acid, a potent iron absorption inhibitor | Dietary supplement | FeFum fortified maize test meal |
| FeSO4 fortified LNSself-made Lipid-based nutritional supplement (LNS) extrinsically fortified and labeled with 6 mg ferrous sulfate (57FeSO4); only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); LNS may be a better food matrix for iron supplementation compared to maize-based porridge; contains canola oil, peanut paste, milk powder, sugar, maltodextrin and palm stearin | Dietary supplement | FeSO4 fortified LNS |
| FeSO4 supplement170 mg iron tablets as FeSO4 (containing 55 mg of elemental iron) with 6 mg extrinsically labeled 57Fe; will be given together with a glass of water; only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); | Dietary supplement | FeSO4 supplement |
| FeSO4 fortified fruit juiceFruit juice labeled with 12 mg 57Fe as FeSO4; in the group for iron sufficient children | Dietary supplement | FeSO4 fortified fruit juice |
Primary outcome
Fractional iron absorption
Time frame: Measured 14 days after consumption of the 3 different types of iron vehicles (Days 17 and 31); Enrichment shift of iron isotopes into red blood cells from Day 31 to 451
Iron absorption will be measured from the 3 different types of iron vehicles from the iron deficient group (FeFum fortified maize porridge, FeSO4 containing LNS, FeSO4 supplement). It is estimated that iron absorption is lower in HIV infected children.
12 secondary outcomes
Hemoglobin in g/dL (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Plasma ferritin in µg/L (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Soluble transferrin receptor in mg/L (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Transferrin saturation in % (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Erythropoetin (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
C-reactive protein in mg/L (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
alpha-1-glycoprotein in g/L (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Plasma hepcidin (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Interleukin-6 (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Intestinal fatty acid binding protein 1 and 2 (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Lipopolysaccharide binding protein (in blood)
Time frame: Days -1, 17 (in iron deficient children), 31, 151, 271, 361, 451
Fecal calprotectin (in stool)
Time frame: Days -1, 31 and 121 (in iron deficient children)
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 14 Sep 2021.
- Derived from this study: PubMed 36992541Goosen C, Proost S, Baumgartner J, Mallick K, Tito RY, Barnabas SL, Cotton MF, Zimmermann MB, Raes J, Blaauw R. Associations of HIV and iron status with gut microbiota composition, gut inflammation and gut integrity in South African school-age children: a two-way factorial case-control study. J Hum Nutr Diet. 2023 Jun;36(3):819-832. doi: 10.1111/jhn.13171. Epub 2023 Apr 16.
- Derived from this study: PubMed 34997267Goosen C, Proost S, Tito RY, Baumgartner J, Barnabas SL, Cotton MF, Zimmermann MB, Raes J, Blaauw R. The effect of oral iron supplementation on the gut microbiota, gut inflammation, and iron status in iron-depleted South African school-age children with virally suppressed HIV and without HIV. Eur J Nutr. 2022 Jun;61(4):2067-2078. doi: 10.1007/s00394-021-02793-9. Epub 2022 Jan 8.
- Derived from this study: PubMed 33809705Goosen C, Baumgartner J, Mikulic N, Barnabas SL, Cotton MF, Zimmermann MB, Blaauw R. Examining Associations of HIV and Iron Status with Nutritional and Inflammatory Status, Anemia, and Dietary Intake in South African Schoolchildren. Nutrients. 2021 Mar 16;13(3):962. doi: 10.3390/nu13030962.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeFum fortified maize test meal, FeSO4 fortified LNS and FeSO4 supplement in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in South Africa.
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 12 inclusion and 5 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 14 Sep 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 South Africa. 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?
Fractional iron absorption (time frame: Measured 14 days after consumption of the 3 different types of iron vehicles (Days 17 and 31); Enrichment shift of iron isotopes into red blood cells from Day 31 to 451). 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 NCT03572010, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.