Iron Deficiency Anemia of PregnancyNCT04074707
Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy
A study testing Labeled iron solution (60mg and 120mg Ferrous Fumarate) in people with Iron Deficiency Anemia of Pregnancy, run by Swiss Federal Institute of Technology at 1 site in Thailand.
Trial summary
Iron deficiency anemia (IDA) is common during pregnancy and has adverse effects on the mother, fetus and newborn. Oral iron supplements are usually recommended to prevent ID/IDA during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy
- What is being tested?
- Labeled iron solution (60mg and 120mg Ferrous Fumarate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 24 Oct 2019to 30 Jun 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- gestational week 14-16 at study start
- singleton pregnancy
- Serum ferritin SF <60 µg/L
- non-anemic or mildly anemic, defined as hemoglobin (Hb) >10 g/dL
- female aged 18-45 years
- healthy Thai woman
Who cannot join
- acute or chronic disease
- taking medications that could influence iron absorption
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Oral Iron Supplementation Regimens During Pregnancy Using Serum Hepcidin Profiles and Iron Stable Isotopes: Defining a Dosing Regimen With Maximal Absorption and Minimal Gastrointestinal Side Effects
Iron deficiency anemia (IDA) is common during pregnancy and has adverse effects on the mother, fetus and newborn. Oral iron supplements are usually recommended to prevent ID/IDA during pregnancy.
The aim of this study is to define an iron supplementation schedule with maximal absorption using serum hepcidin profiles and stable iron isotopes in pregnant women. In this randomized, open-label trial, fractional and total iron absorption will be compared from daily dosing with 60 mg iron versus alternate day and every third day dosing with 120 mg iron in pregnant Thai women with low iron stores (n=28) during their second trimester of pregnancy.
This study could have wide impact, providing the evidence base for revised, improved recommendations for iron supplementation during pregnancy.
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Being tested
- Labeled iron solution (60mg and 120mg Ferrous Fumarate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labeled iron solution (60mg and 120mg Ferrous Fumarate)Dietary supplement
3 doses of 60mg iron as ferrous fumarate are given on one consecutive day and one alternate day (e.g., days 1, 2, 4); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one 3rd day (e.g., days 37, 38, 41). Iron doses are labeled with 4mg of a stable isotope in 200ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with 60mg iron daily vs alternate day dosing, 120mg daily vs alternate day dosing or 120mg daily vs every-third day dosing.
| Study group | Role | What they receive |
|---|---|---|
| oral iron supplementation | Experimental | Participants go through 3 cycles of oral iron Supplementation (60mg daily vs alternate day dosing, 120mg daily vs alternate day dosing, 120mg daily vs every third-day dosing) Receives: Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption in %
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 18
Fractional iron absorption in %
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 35
Fractional iron absorption in %
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Total iron absorption in %
Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose
Measured: Day 18
Total iron absorption in %
Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose
Measured: Day 35
Total iron absorption in %
Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose
Measured: Day 53
Serum Hepcidin
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Serum Hepcidin
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 2
Serum Hepcidin
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 4
Serum Hepcidin
in the morning before first supplement intake of 120mg daily vs alternate day cycle
Measured: Day 18
Serum Hepcidin
in the morning before second supplement intake of 120mg daily vs alternate day cycle
Measured: Day 19
Serum Hepcidin
in the morning before third supplement intake of 120mg daily vs alternate day cycle
Measured: Day 21
Serum Hepcidin
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Serum Hepcidin
in the morning before second supplement intake of the 120mg daily vs every third day cycle
Measured: Day 36
Serum Hepcidin
in the morning before third supplement intake of the 120mg daily vs every third day cycle
Measured: Day 39
Serum Hepcidin
in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
Measured: Day 53
Secondary outcomes (51)
Serum Ferritin (SF)
in the morning before first supplement intake
Measured: Screening
Serum Ferritin (SF)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Serum Ferritin (SF)
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Serum Ferritin (SF)
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Serum Ferritin (SF)
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Hemoglobin (Hb)
in the morning before first supplement intake
Measured: Screening
Hemoglobin (Hb)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Hemoglobin (Hb)
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Hemoglobin (Hb)
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Hemoglobin (Hb)
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Soluble transferrin receptor (sTfR)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Soluble transferrin receptor (sTfR)
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Soluble transferrin receptor (sTfR)
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Soluble transferrin receptor (sTfR)
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
C-reactive protein (CRP)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
C-reactive protein (CRP)
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
C-reactive protein (CRP)
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
C-reactive protein (CRP)
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Alpha-1-acid glycoprotein (AGP)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Alpha-1-acid glycoprotein (AGP)
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Alpha-1-acid glycoprotein (AGP)
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Alpha-1-acid glycoprotein (AGP)
in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Serum Hepcidin
in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Serum Hepcidin
in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Serum Hepcidin
in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Serum Iron (SFe)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Serum Iron (SFe)
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 2
Serum Iron (SFe)
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 4
Serum Iron (SFe)
in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Serum Iron (SFe)
in the morning before the first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Serum Iron (SFe)
in the morning before the second supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 19
Serum Iron (SFe)
in the morning before the third supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 21
Serum Iron (SFe)
in the afternoon after the first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Serum Iron (SFe)
in the morning before the first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Serum Iron (SFe)
in the morning before the second supplement intake of the 120mg daily vs every third day cycle
Measured: Day 36
Serum Iron (SFe)
in the morning before the third supplement intake of the 120mg daily vs every third day cycle
Measured: Day 39
Serum Iron (SFe)
in the morning 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Serum Iron (SFe)
in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Total Iron Binding Capacity (TIBC)
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Total Iron Binding Capacity (TIBC)
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 2
Total Iron Binding Capacity (TIBC)
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 4
Total Iron Binding Capacity (TIBC)
in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle
Measured: Day 1
Total Iron Binding Capacity (TIBC)
in the morning before first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Total Iron Binding Capacity (TIBC)
in the morning before second supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 19
Total Iron Binding Capacity (TIBC)
in the morning before third supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 21
Total Iron Binding Capacity (TIBC)
in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle
Measured: Day 18
Total Iron Binding Capacity (TIBC)
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Measured: Day 35
Total Iron Binding Capacity (TIBC)
in the morning before second supplement intake of the 120mg daily vs every third day cycle
Measured: Day 36
Total Iron Binding Capacity (TIBC)
in the morning before third supplement intake of the 120mg daily vs every third day cycle
Measured: Day 39
Total Iron Binding Capacity (TIBC)
in the morning 14 after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Total Iron Binding Capacity (TIBC)
in the afternoon 14 after last supplement intake of the 120mg daily vs every third day cycle
Measured: Day 53
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start24 Oct 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Deficiency Anemia of PregnancyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the 60mg daily vs alternate day, 120mg daily vs alternate day or 120mg daily vs every third day supplementation cycle.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074707
- Sponsor's protocol ID
- TIPS
- Status last verified
- Jul 2024
- First submitted
- 27 Aug 2019
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Siebenthal HK, Moretti D, Zimmermann MB, Stoffel NU. Effect of dietary factors and time of day on iron absorption from oral iron supplements in iron deficient women. Am J Hematol. 2023 Sep;98(9):1356-1363. doi: 10.1002/ajh.26987. Epub 2023 Jun 26.
PubMed 37357807
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Oral Iron Supplementation Regimens During Pregnancy Using Serum Hepcidin Profiles and Iron Stable Isotopes: Defining a Dosing Regimen With Maximal Absorption and Minimal Gastrointestinal Side Effects
- ClinicalTrials.gov ID
- NCT04074707
- Acronym / sponsor ID
- TIPS
- Conditions
- Iron Deficiency Anemia of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 30 Aug 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 anemia (IDA) is common during pregnancy and has adverse effects on the mother, fetus and newborn. Oral iron supplements are usually recommended to prevent ID/IDA during pregnancy.
The aim of this study is to define an iron supplementation schedule with maximal absorption using serum hepcidin profiles and stable iron isotopes in pregnant women. In this randomized, open-label trial, fractional and total iron absorption will be compared from daily dosing with 60 mg iron versus alternate day and every third day dosing with 120 mg iron in pregnant Thai women with low iron stores (n=28) during their second trimester of pregnancy.
This study could have wide impact, providing the evidence base for revised, improved recommendations for iron supplementation during pregnancy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the 60mg daily vs alternate day, 120mg daily vs alternate day or 120mg daily vs every third day supplementation cycle.
| Arm | Type | Receives |
|---|---|---|
| oral iron supplementation | Experimental | Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate)Participants go through 3 cycles of oral iron Supplementation (60mg daily vs alternate day dosing, 120mg daily vs alternate day dosing, 120mg daily vs every third-day dosing) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- gestational week 14-16 at study start
- singleton pregnancy
- Serum ferritin SF <60 µg/L
- non-anemic or mildly anemic, defined as hemoglobin (Hb) >10 g/dL
- female aged 18-45 years
Key exclusion criteria (3 listed)
- acute or chronic disease
- taking medications that could influence iron absorption
- smoking
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 |
|---|---|---|
| Labeled iron solution (60mg and 120mg Ferrous Fumarate)3 doses of 60mg iron as ferrous fumarate are given on one consecutive day and one alternate day (e.g., days 1, 2, 4); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one 3rd day (e.g., days 37, 38, 41). Iron doses are labeled with 4mg of a stable isotope in 200ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with 60mg iron daily vs alternate day dosing, 120mg daily vs alternate day dosing or 120mg daily vs every-third day dosing. | Dietary supplement | oral iron supplementation |
Primary outcome
Fractional iron absorption in %
Time frame: Day 18
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 60mg daily vs alternate day cycle
Fractional iron absorption in %
Time frame: Day 35
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs alternate day cycle
Fractional iron absorption in %
Time frame: Day 53
Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle
Total iron absorption in %
Time frame: Day 18
Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose
Total iron absorption in %
Time frame: Day 35
Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose
Total iron absorption in %
Time frame: Day 53
Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose
Serum Hepcidin
Time frame: Day 1
in the morning before first supplement intake of the 60mg daily vs alternate day cycle
Serum Hepcidin
Time frame: Day 2
in the morning before second supplement intake of the 60mg daily vs alternate day cycle
Serum Hepcidin
Time frame: Day 4
in the morning before third supplement intake of the 60mg daily vs alternate day cycle
Serum Hepcidin
Time frame: Day 18
in the morning before first supplement intake of 120mg daily vs alternate day cycle
Serum Hepcidin
Time frame: Day 19
in the morning before second supplement intake of 120mg daily vs alternate day cycle
Serum Hepcidin
Time frame: Day 21
in the morning before third supplement intake of 120mg daily vs alternate day cycle
Serum Hepcidin
Time frame: Day 35
in the morning before first supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin
Time frame: Day 36
in the morning before second supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin
Time frame: Day 39
in the morning before third supplement intake of the 120mg daily vs every third day cycle
Serum Hepcidin
Time frame: Day 53
in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle
51 secondary outcomes
Serum Ferritin (SF)
Time frame: Screening
Serum Ferritin (SF)
Time frame: Day 1
Serum Ferritin (SF)
Time frame: Day 18
Serum Ferritin (SF)
Time frame: Day 35
Serum Ferritin (SF)
Time frame: Day 53
Hemoglobin (Hb)
Time frame: Screening
Hemoglobin (Hb)
Time frame: Day 1
Hemoglobin (Hb)
Time frame: Day 18
Hemoglobin (Hb)
Time frame: Day 35
Hemoglobin (Hb)
Time frame: Day 53
Soluble transferrin receptor (sTfR)
Time frame: Day 1
Soluble transferrin receptor (sTfR)
Time frame: Day 18
Soluble transferrin receptor (sTfR)
Time frame: Day 35
Soluble transferrin receptor (sTfR)
Time frame: Day 53
C-reactive protein (CRP)
Time frame: Day 1
C-reactive protein (CRP)
Time frame: Day 18
C-reactive protein (CRP)
Time frame: Day 35
C-reactive protein (CRP)
Time frame: Day 53
Alpha-1-acid glycoprotein (AGP)
Time frame: Day 1
Alpha-1-acid glycoprotein (AGP)
Time frame: Day 18
Alpha-1-acid glycoprotein (AGP)
Time frame: Day 35
Alpha-1-acid glycoprotein (AGP)
Time frame: Day 53
Serum Hepcidin
Time frame: Day 1
Serum Hepcidin
Time frame: Day 18
Serum Hepcidin
Time frame: Day 53
Serum Iron (SFe)
Time frame: Day 1
Serum Iron (SFe)
Time frame: Day 2
Serum Iron (SFe)
Time frame: Day 4
Serum Iron (SFe)
Time frame: Day 1
Serum Iron (SFe)
Time frame: Day 18
Serum Iron (SFe)
Time frame: Day 19
Serum Iron (SFe)
Time frame: Day 21
Serum Iron (SFe)
Time frame: Day 18
Serum Iron (SFe)
Time frame: Day 35
Serum Iron (SFe)
Time frame: Day 36
Serum Iron (SFe)
Time frame: Day 39
Serum Iron (SFe)
Time frame: Day 53
Serum Iron (SFe)
Time frame: Day 53
Total Iron Binding Capacity (TIBC)
Time frame: Day 1
Total Iron Binding Capacity (TIBC)
Time frame: Day 2
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 24 Jul 2024.
- Derived from this study: PubMed 37357807von Siebenthal HK, Moretti D, Zimmermann MB, Stoffel NU. Effect of dietary factors and time of day on iron absorption from oral iron supplements in iron deficient women. Am J Hematol. 2023 Sep;98(9):1356-1363. doi: 10.1002/ajh.26987. Epub 2023 Jun 26.
- 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 Labeled iron solution (60mg and 120mg Ferrous Fumarate) in people with Iron Deficiency Anemia of Pregnancy, run by Swiss Federal Institute of Technology at 1 site in Thailand.
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 6 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: finished, as of the sponsor's last update on 24 Jul 2024. 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 Thailand. 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 in % (time frame: Day 18). The study lists 16 primary outcomes in all. 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 NCT04074707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.