Iron Deficiency AnemiaNCT05545527
Neuroimaging Ancillary Study
An observational study of Iron Deficiency Anemia and Iron Deficiency Anemia of Pregnancy, run by Thomas Jefferson University at 1 site in India.
Trial summary
As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Iron Deficiency Anemia, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus
- What is being tested?
- Ferric carboxymaltose, Iron isomaltoside and Ferric Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 184 participants
- Where
- 1 siteIndia
- Study dates
- 21 Feb 2023to 7 Apr 2025
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: For this ancillary study, only infants of randomized RAPIDIRON Trial (NCT05358509) participants recruited in Karnataka State will be eligible for participation.
Who may be able to join
- For the maternal participant in the parent RAPIDIRON Trial - a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age)
- An indication of the pregnant woman's intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits;
- Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in this ancillary trial; and
- Concurrent participation in the RAPIDIRON-KIDS follow-up study (NCT05504863).
Who cannot join
- If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study;
- If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroimaging Ancillary Study of the IV Iron RAPIDIRON Trial
As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.
Read the detailed description
The hypothesis of this study is as follows:
- Reduced iron availability through fetal development impacts fundamental early neurodevelopmental processes, including neurogenesis of the hippocampus, amygdala, and other 'core' deep brain basal ganglia regions (e.g., globus pallidus); and myelination of the brain's white matter connecting these deep brain structures and higher-order cortical regions involved in motor, memory, and executive functioning.
The specific aims of this Neuroimaging Ancillary Study are:
- To determine impact of the IV iron intervention compared to oral iron on specific markers of brain development; and
- As a secondary analysis, to explore whether infant sex acts as a moderator of treatment on these specific brain development markers.
This study will recruit pregnant mothers currently participating in the parent RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in this Neuroimaging Ancillary Study. Participation in this Ancillary Study will involve assessments at 32-35 weeks fetal gestational age, birth, 4 months, 12 months, and 24 months post-delivery. This will involve a fetal MRI and three post-birth MRIs conducted with the offspring to collect the main neuroimaging measures. In addition, we will collect various secondary offspring and maternal measures including child auditory brain response; maternal depression, anxiety, perceived stress, and empowerment; hair cortisol; and breastmilk micronutrient analysis.
Please see the protocol for additional details.
- Conditions
- Iron Deficiency Anemia, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus, Iron Deficiency Anemia Treatment, Fetal Neurodevelopmental Disorder, Child Development
- Being tested
- Ferric carboxymaltose, Iron isomaltoside, Ferric Sulfate
- Keywords
- India, Neuroimaging, Intravenous iron, MRI, Pediatrics
- 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.
Ferric carboxymaltoseDrug
As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy.
Iron isomaltosideDrug
Also called Ferric derisomaltose
As part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy.
Ferric SulfateDrug
Also called Ferric sulphate
As part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron.
| Study group | Role | What they receive |
|---|---|---|
| RAPIDIRON IV iron intervention arm 1 | Maternal participants in this arm were given a single dose of an IV iron formulation - ferric carboxymaltose - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age. Receives: Drug: Ferric carboxymaltose | |
| RAPIDIRON IV iron intervention arm 2 | Maternal participants in this arm were given a single dose of an IV iron formulation - iron isomaltoside - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age. Receives: Drug: Iron isomaltoside | |
| RAPIDIRON active comparator arm | Maternal participants in this arm of the RAPIDIRON Trial were given ferrous sulfate tablets with 60mg elemental iron each and instructed to take two per day (one in the morning and one at night) throughout their pregnancy. Receives: Drug: Ferric Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal hippocampal volume
Fetal hippocampus volume, measured via fetal MRI
Measured: 32-35 weeks fetal gestational age
Fetal diffusion parameters: fractional anisotropy (FA)
Fetal white matter microstructure will be measured via FA at the posterior limb of internal capsule using fetal MRI
Measured: 32-35 weeks fetal gestational age
Fetal diffusion parameters: mean diffusivity
Fetal white matter microstructure will be measured via MD at the posterior limb of internal capsule using fetal MRI
Measured: 32-35 weeks fetal gestational age
Secondary outcomes (8)
Fetal sub-cortical gray matter structures
Fetal sub-cortical gray matter structures in the brain using fetal MRI
Measured: 32-35 weeks fetal gestational age
Fetal white matter microstructure measures
Additional fetal white matter microstructure measures using fetal MRI, including qualitative T2 MRI measures and NODDI metrics
Measured: 32-35 weeks fetal gestational age
Child hippocampal volume
Child hippocampal volume, measured via MRI
Measured: 4 - 24 months of age
Child white matter volume
Child white matter volume, measured via MRI
Measured: 4 - 24 months of age
Child white matter microstructure
Child white matter microstructure, including myelination, fiber coherence, and architecture, measured via MRI
Measured: 4 - 24 months of age
Child white matter connectivity
Child white matter connectivity, measured via MRI
Measured: 4 - 24 months of age
Child functional connectivity
Child functional connectivity, measured via MRI
Measured: 4 - 24 months of age
Child cerebral metabolism
Child cerebral metabolism, including perfusion and spectroscopy, measured via MRI
Measured: 4 - 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start21 Feb 2023
- Primary completion14 Feb 2024
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College
- Responsible party
- Sponsor
- Investigators
- Richard Derman, MD, MPH, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545527
- Sponsor's protocol ID
- U32401
- Status last verified
- Apr 2025
- First submitted
- 14 Sep 2022
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Ancillary Study of the IV Iron RAPIDIRON Trial
- ClinicalTrials.gov ID
- NCT05545527
- Acronym / sponsor ID
- U32401
- Conditions
- Iron Deficiency Anemia, Iron Deficiency Anemia of Pregnancy, Neurodevelopmental Disorder of Foetus, Iron Deficiency Anemia Treatment, Fetal Neurodevelopmental Disorder, Child Development
- Keywords
- India, Neuroimaging, Intravenous iron, MRI, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 19 Sep 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.
As a follow-up to the RAPIDIRON Trial (NCT05358509), and in combination with the RAPIDIRON-KIDS Study (NCT05504863), this study will involve infants of RAPIDIRON Trial participants recruited at one site in Karnataka and is designed to implement a magnetic resonance imaging (MRI) protocol and incorporate neuroimaging measures. Implementation of this study will promote an understanding of the effects on fetal and neonatal brain development, including iron deposition in brain tissues, when a woman is treated for iron deficiency anemia (IDA) by either (a) providing her oral iron tablets and instructions for use; or (b) administering a single-dose IV iron infusion for the treatment of IDA during pregnancy.
Detailed description
The hypothesis of this study is as follows:
- Reduced iron availability through fetal development impacts fundamental early neurodevelopmental processes, including neurogenesis of the hippocampus, amygdala, and other 'core' deep brain basal ganglia regions (e.g., globus pallidus); and myelination of the brain's white matter connecting these deep brain structures and higher-order cortical regions involved in motor, memory, and executive functioning.
The specific aims of this Neuroimaging Ancillary Study are:
- To determine impact of the IV iron intervention compared to oral iron on specific markers of brain development; and
- As a secondary analysis, to explore whether infant sex acts as a moderator of treatment on these specific brain development markers.
This study will recruit pregnant mothers currently participating in the parent RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in this Neuroimaging Ancillary Study. Participation in this Ancillary Study will involve assessments at 32-35 weeks fetal gestational age, birth, 4 months, 12 months, and 24 months post-delivery. This will involve a fetal MRI and three post-birth MRIs conducted with the offspring to collect the main neuroimaging measures. In addition, we will collect various secondary offspring and maternal measures including child auditory brain response; maternal depression, anxiety, perceived stress, and empowerment; hair cortisol; and breastmilk micronutrient analysis.
Please see the protocol for additional details.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RAPIDIRON IV iron intervention arm 1 | – | Drug: Ferric carboxymaltoseMaternal participants in this arm were given a single dose of an IV iron formulation - ferric carboxymaltose - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age. |
| RAPIDIRON IV iron intervention arm 2 | – | Drug: Iron isomaltosideMaternal participants in this arm were given a single dose of an IV iron formulation - iron isomaltoside - during pregnancy as part of their participation in the parent RAPIDIRON Trial. Participants weighing 50kg and over received a single dose having 1000mg of iron, with others receiving a lower dose as determined by a formula used by the manufacturer (20mg iron/kg body weight). This was given between 14 and 17 weeks fetal gestational age. |
| RAPIDIRON active comparator arm | – | Drug: Ferric SulfateMaternal participants in this arm of the RAPIDIRON Trial were given ferrous sulfate tablets with 60mg elemental iron each and instructed to take two per day (one in the morning and one at night) throughout their pregnancy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- For this ancillary study, only infants of randomized RAPIDIRON Trial (NCT05358509) participants recruited in Karnataka State will be eligible for participation.
Key inclusion criteria (4 listed)
- For the maternal participant in the parent RAPIDIRON Trial - a pregnancy that has not gone beyond the period for obtaining a fetal MRI (by scanning the mother at 32-35 weeks fetal gestational age)
- An indication of the pregnant woman's intent to deliver in the study area and to reside there so as to be available not only to complete RAPIDIRON participation but also to allow her and her offspring to participate in ancillary study visits;
- Informed consent of the pregnant RAPIDIRON participant for her participation and that of her offspring in this ancillary trial; and
- Concurrent participation in the RAPIDIRON-KIDS follow-up study (NCT05504863).
Key exclusion criteria (2 listed)
- If a fetal brain anomaly is found when the maternal participant undergoes an MRI at 32-35 weeks fetal gestational age, the dyad would be excluded from the ancillary study;
- If any of the following occur, this would result in dyad ineligibility for participation or continued participation in this ancillary study: maternal blood transfusion after enrollment, a pregnancy ending in stillbirth, neonatal death, diagnosis in the offspring of moderate to severe hypoxic-ischemic encephalopathy (or HIE), and/or blood transfusion to the offspring.
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 |
|---|---|---|
| Ferric carboxymaltoseAs part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 1 were given a single dose of ferric carboxymaltose between 14 and 17 weeks of pregnancy. | Drug | RAPIDIRON IV iron intervention arm 1 |
| Iron isomaltosideAlso: Ferric derisomaltoseAs part of the RAPIDIRON Trial, maternal participants randomized to intervention arm 2 were given a single dose of iron isomaltoside between 14 and 17 weeks of pregnancy. | Drug | RAPIDIRON IV iron intervention arm 2 |
| Ferric SulfateAlso: Ferric sulphateAs part of the RAPIDIRON Trial, maternal participants randomized to the active comparator arm were given 200 ferrous sulfate tablets immediately after randomization (~12 weeks of pregnancy). Participants were instructed to take two tablets a day, with each tablet containing 60mg elemental iron. | Drug | RAPIDIRON active comparator arm |
Primary outcome
Fetal hippocampal volume
Time frame: 32-35 weeks fetal gestational age
Fetal hippocampus volume, measured via fetal MRI
Fetal diffusion parameters: fractional anisotropy (FA)
Time frame: 32-35 weeks fetal gestational age
Fetal white matter microstructure will be measured via FA at the posterior limb of internal capsule using fetal MRI
Fetal diffusion parameters: mean diffusivity
Time frame: 32-35 weeks fetal gestational age
Fetal white matter microstructure will be measured via MD at the posterior limb of internal capsule using fetal MRI
8 secondary outcomes
Fetal sub-cortical gray matter structures
Time frame: 32-35 weeks fetal gestational age
Fetal white matter microstructure measures
Time frame: 32-35 weeks fetal gestational age
Child hippocampal volume
Time frame: 4 - 24 months of age
Child white matter volume
Time frame: 4 - 24 months of age
Child white matter microstructure
Time frame: 4 - 24 months of age
Child white matter connectivity
Time frame: 4 - 24 months of age
Child functional connectivity
Time frame: 4 - 24 months of age
Child cerebral metabolism
Time frame: 4 - 24 months of age
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 16 Apr 2025.
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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.
Richard Derman, MD, MPH principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Iron Deficiency Anemia of Pregnancy, run by Thomas Jefferson University at 1 site in India.
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 4 inclusion and 2 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 16 Apr 2025. 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 India. 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?
Fetal hippocampal volume (time frame: 32-35 weeks fetal gestational age). The study lists 3 primary outcomes in all. 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 16 Apr 2025.