Iron Deficiency AnemiaRAPIDIRON-KIDSNCT05504863
RAPIDIRON Trial Follow-up Study: RAPIDIRON-KIDS Study
An observational study of Iron Deficiency Anemia and Neurodevelopmental Abnormality, run by Thomas Jefferson University at 3 sites in India.
Trial summary
As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Iron Deficiency Anemia, Neurodevelopmental Abnormality, Autism Spectrum Disorder
- What is being tested?
- Ferric carboxymaltose, Iron isomaltoside and Ferric Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 538 participants
- Where
- 3 sitesIndia
- Study dates
- 11 Oct 2022to Jan 2026
- 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: Participants of this study are mother-infant dyads consisting of women, residing in Karnataka State (India), who were randomized and treated for iron-deficiency anemia (IDA) during the RAPIDIRON Trial and their newborns.
Who may be able to join
- Informed consent of the RAPIDIRON Trial participant for their study inclusion and that of their offspring for the RAPIDIRON-KIDS Study
- Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research are for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits
- For the offspring - live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother
Who cannot join
- Unwillingness of maternal participant to provide RAPIDIRON-KIDS Study consent for herself and her offspring
Trial locations and contacts
3 sites in 1 country.
India3 sites
S. Nijalingappa Medical College
Bagalkot, Karnataka
Jawaharlal Nehru Medical College
Belagavi, Karnataka
Raichur Institute of Medical Sciences
Rāichūr, Karnataka
About this study
Official title: Effect of Iron Supplementation During Pregnancy on Neurodevelopmental Status of Babies
As a follow-up to the RAPIDIRON Trial (NCT05358509), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.
Read the detailed description
The RAPIDIRON-KIDS Study has two primary hypotheses:
- Infants born to RAPIDIRON Trial maternal participants from the intravenous (IV) iron arms will have higher hemoglobin and ferritin levels at birth (determined by cord blood) and at 4 months of age compared to infants born to mothers in the oral arm; and
- Offspring born to RAPIDIRON Trial participants who received IV iron treatment will have higher developmental quotients (DQs) on the cognitive domain of the Bayley Scales of Infant Development (BSID) at 2 years of age compared to offspring born to RAPIDIRON Trial participants given oral iron treatment.
The specific aims of this study are as follows:
- To provide evidence that a single-dose of IV iron (either ferric carboxymaltose or iron isomaltoside, also known as ferric derisomaltose) given to pregnant women in the second trimester during the RAPIDIRON Trial will prove more effective for prevention of neonatal and postnatal iron deficiency in the offspring than the oral iron given to pregnant women per the parent trial protocol
- To assess if the offspring of women in the parent trial IV iron arms have better neurodevelopmental outcomes compared to the offspring of women treated with oral iron; and
- To determine longer-term hematologic effects in previously randomized mothers by obtaining ongoing hematologic indices, documented history of transfusion and hospitalization, and quality of life based on the use of a validated instrument.
This study will recruit pregnant mothers currently participating in the RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in the RAPIDIRON-KIDS Study. Participation in RAPIDIRON-KIDS will involve assessments at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months of age. In addition to iron status, anthropometry, and questionnaires relating to child feeding and maternal quality of life, the following neurobehavioral tests will be utilized to assess the offspring at various timepoints: Preferential Looking Test, Ages \& Stages Questionnaire 3, Bayley Scales of Infant Development, Behavioral Rating Scale, India Scale for Assessment of Autism, and the Child Behavior Checklist for Ages 1.5-5.
Please see the protocol for additional details.
- Being tested
- Ferric carboxymaltose, Iron isomaltoside, Ferric Sulfate
- Keywords
- Anemia, Iron Deficiency Anemia, Intravenous iron, India, Low birth weight, Pediatrics, Neurodevelopment
- Medical subject headings
- Anemia, Iron-Deficiency, Autism Spectrum Disorder, Anemia
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.
Offspring hemoglobin
Offspring hemoglobin concentration in g/dL
Measured: Birth
Offspring hemoglobin
Offspring hemoglobin concentration in g/dL
Measured: 4 months of age
Offspring ferritin
Offspring serum ferritin concentration in ng/mL
Measured: Birth
Offspring ferritin
Offspring serum ferritin concentration in ng/mL
Measured: 4 months of age
Cognitive Domain of Bayley Scales of Infant Development (BSID)
Developmental quotient (DQ) on the cognitive domain of the Bayley Scales of Infant Development (BSID), conducted at 24 months of age. The Cognitive Domain of the BSID-IV contains 81 items, each item with a minimum score of 0 and a maximum score of 2. A lower score is a bad outcome and a higher score is a good outcome.
Measured: 24 months of age
Secondary outcomes (16)
Offspring hemoglobin
Offspring hemoglobin concentration in g/dL
Measured: 12 months of age
Offspring ferritin
Offspring serum ferritin concentration in ng/mL
Measured: 12 months of age
Preferential Looking Time
Performance on Preferential Looking Time assessment - scored as the percentage of time spent looking at the novel object during the test phase
Measured: 4 and 12 months of age
Motor and language domains of the Bayley Scales of Infant Development (BSID)
Developmental quotient (DQ) on the motor and language domains of the Bayley Scales of Infant Development (BSID), conducted at 24 months of age. The motor domain of the BSID-IV contains 79 items, and the language domain contains 104 items. Minimum score on each item is 0, maximum score is 2. A lower score is a bad outcome and a higher score is a good outcome.
Measured: 24 months of age
Bayley Scales of Infant Development (BSID)
Developmental quotients (DQs) on all domains of the Bayley Scales of Infant Development (BSID), conducted at 36 months of age. There are 5 domains, each many items. Each item has a minimum score of 0 and a maximum score of 2. A lower score is a bad outcome and a higher score is a good outcome.
Measured: 36 months of age
Behavior Rating Scale
Score on the Behavior Rating Scale, as coded from a video recording undergoing the Bayley Scales of Infant Development (BSID). Each child is rated across nine behavioral domains. The minimum score in each domain is 0 and the maximum score is 5, with higher scores indicating more optimal behaviors.
Measured: 24 months of age
Ages & Stages Questionnaire 3
Accepted and validated screening tool for neurodevelopment. Minimum score of 0, maximum score of 60. Lower score is a bad outcome, higher score is a good outcome.
Measured: 12 months of age
Child Behavior Checklist for Ages 1.5-5
A parent-report questionnaire assessing internalizing and externalizing behaviors. Standardized t-scores will result, with a mean of 50 and standard deviation of 10. Higher scores indicate more symptoms (emotional/behavioral) and a worse outcome.
Measured: 24 and 36 months of age
India Scale of Assessment for Autism
A standardized screening tool for autism, validated for the Indian population. 40 items are rated from 1 to 5, with a higher score indicating increasing severity.
Measured: 36 months of age
Offspring weight
Offspring weight measured in kg
Measured: 4, 12, 24, and 36 months of age
Offspring height
Offspring height measured in cm
Measured: 6 weeks, 4, 12, 24, and 36 months of age
Offspring head circumference
Offspring head circumference measured in cm
Measured: Birth, 4, 12, 24, and 36 months of age
Infant and Young Child Feeding Practices
A composite questionnaire used to measure feeding practices based upon breastfeeding, dietary diversity, meal frequency, iron supplementation, and iron-fortified foods.
Measured: Birth, 6 weeks, 4, 12, and 24 months of age
Maternal hemoglobin concentration
Maternal hemoglobin concentration measured in g/dL
Measured: 4, 12, and 24 month visits
Maternal ferritin
Maternal serum ferritin concentration in ng/mL
Measured: 4, 12, and 24 month visits
Maternal well-being/quality of life
Maternal well-being/quality of life, as measured by the World Health Organization Disability Assessment Schedule II (WHODAS-II). Uses 36 items to measure health and disability across six domains of life - cognitive, mobility, self care, relationship, life activities, and participation. Each item is given a score from 0 to 4, and all item scores are summed. Higher scores mean worse outcomes and higher disability status.
Measured: 4 and 12 month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start11 Oct 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
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 AnemiaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Richard Derman, MD, MPH, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504863
- Sponsor's protocol ID
- R-2111-07169
- Acronym
- RAPIDIRON-KIDS
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Derman RJ, Bellad RB, Bellad MB, Bradford-Rogers J, Georgieff MK, Aghai ZH, Thind S, Auerbach M, Boelig R, Leiby BE, Short V, Yogeshkumar S, Charantimath US, Somannavar MS, Mallapur AA, Pol R, Ramadurg U, Sangavi R, Peerapur BV, Banu N, Patil PS, Patil AP, Roy S, Vastrad P, Wallace D, Shah H, Goudar SS. RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study. Trials. 2023 Dec 20;24(1):818. doi: 10.1186/s13063-023-07740-z.
PubMed 38124098
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron Supplementation During Pregnancy on Neurodevelopmental Status of Babies
- ClinicalTrials.gov ID
- NCT05504863
- Acronym / sponsor ID
- RAPIDIRON-KIDS / R-2111-07169
- Keywords
- Anemia, Iron Deficiency Anemia, Intravenous iron, India, Low birth weight, Pediatrics, Neurodevelopment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College, S. Nijalingappa Medical College, Raichur Institute of Medical Sciences
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Aug 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), this study will follow the previously randomized mothers as well as their offspring after birth to assess neurodevelopmental, hematologic, and health outcomes. The study's overarching goal is to determine if the offspring born to RAPIDIRON Trial mothers in the intravenous iron groups, compared to the oral iron group, will achieve superior neurodevelopment, iron stores, and growth at specific time points during the first three years of life. Differences will be assessed between offspring based on the iron deficiency anemia (IDA) treatment of the mother.
Detailed description
The RAPIDIRON-KIDS Study has two primary hypotheses:
- Infants born to RAPIDIRON Trial maternal participants from the intravenous (IV) iron arms will have higher hemoglobin and ferritin levels at birth (determined by cord blood) and at 4 months of age compared to infants born to mothers in the oral arm; and
- Offspring born to RAPIDIRON Trial participants who received IV iron treatment will have higher developmental quotients (DQs) on the cognitive domain of the Bayley Scales of Infant Development (BSID) at 2 years of age compared to offspring born to RAPIDIRON Trial participants given oral iron treatment.
The specific aims of this study are as follows:
- To provide evidence that a single-dose of IV iron (either ferric carboxymaltose or iron isomaltoside, also known as ferric derisomaltose) given to pregnant women in the second trimester during the RAPIDIRON Trial will prove more effective for prevention of neonatal and postnatal iron deficiency in the offspring than the oral iron given to pregnant women per the parent trial protocol
- To assess if the offspring of women in the parent trial IV iron arms have better neurodevelopmental outcomes compared to the offspring of women treated with oral iron; and
- To determine longer-term hematologic effects in previously randomized mothers by obtaining ongoing hematologic indices, documented history of transfusion and hospitalization, and quality of life based on the use of a validated instrument.
This study will recruit pregnant mothers currently participating in the RAPIDIRON Trial, who will be approached to give consent for themselves and their offspring for participation in the RAPIDIRON-KIDS Study. Participation in RAPIDIRON-KIDS will involve assessments at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months of age. In addition to iron status, anthropometry, and questionnaires relating to child feeding and maternal quality of life, the following neurobehavioral tests will be utilized to assess the offspring at various timepoints: Preferential Looking Test, Ages \& Stages Questionnaire 3, Bayley Scales of Infant Development, Behavioral Rating Scale, India Scale for Assessment of Autism, and the Child Behavior Checklist for Ages 1.5-5.
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
- Participants of this study are mother-infant dyads consisting of women, residing in Karnataka State (India), who were randomized and treated for iron-deficiency anemia (IDA) during the RAPIDIRON Trial and their newborns.
Key inclusion criteria (3 listed)
- Informed consent of the RAPIDIRON Trial participant for their study inclusion and that of their offspring for the RAPIDIRON-KIDS Study
- Expressed intent of the RAPIDIRON Trial participant to remain in the designated Karnataka research are for delivery and during the follow-up period for the RAPIDIRON-KIDS Study to enable participation in study visits
- For the offspring - live-born singleton infants of Karnataka maternal participants randomized and treated in the RAPIDIRON Trial, if consent is provided by the mother
Key exclusion criteria (1 listed)
- Unwillingness of maternal participant to provide RAPIDIRON-KIDS Study consent for herself and her 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
Offspring hemoglobin
Time frame: Birth
Offspring hemoglobin concentration in g/dL
Offspring hemoglobin
Time frame: 4 months of age
Offspring hemoglobin concentration in g/dL
Offspring ferritin
Time frame: Birth
Offspring serum ferritin concentration in ng/mL
Offspring ferritin
Time frame: 4 months of age
Offspring serum ferritin concentration in ng/mL
Cognitive Domain of Bayley Scales of Infant Development (BSID)
Time frame: 24 months of age
Developmental quotient (DQ) on the cognitive domain of the Bayley Scales of Infant Development (BSID), conducted at 24 months of age. The Cognitive Domain of the BSID-IV contains 81 items, each item with a minimum score of 0 and a maximum score of 2. A lower score is a bad outcome and a higher score is a good outcome.
16 secondary outcomes
Offspring hemoglobin
Time frame: 12 months of age
Offspring ferritin
Time frame: 12 months of age
Preferential Looking Time
Time frame: 4 and 12 months of age
Motor and language domains of the Bayley Scales of Infant Development (BSID)
Time frame: 24 months of age
Bayley Scales of Infant Development (BSID)
Time frame: 36 months of age
Behavior Rating Scale
Time frame: 24 months of age
Ages & Stages Questionnaire 3
Time frame: 12 months of age
Child Behavior Checklist for Ages 1.5-5
Time frame: 24 and 36 months of age
India Scale of Assessment for Autism
Time frame: 36 months of age
Offspring weight
Time frame: 4, 12, 24, and 36 months of age
Offspring height
Time frame: 6 weeks, 4, 12, 24, and 36 months of age
Offspring head circumference
Time frame: Birth, 4, 12, 24, and 36 months of age
Infant and Young Child Feeding Practices
Time frame: Birth, 6 weeks, 4, 12, and 24 months of age
Maternal hemoglobin concentration
Time frame: 4, 12, and 24 month visits
Maternal ferritin
Time frame: 4, 12, and 24 month visits
Maternal well-being/quality of life
Time frame: 4 and 12 month visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 38124098Derman RJ, Bellad RB, Bellad MB, Bradford-Rogers J, Georgieff MK, Aghai ZH, Thind S, Auerbach M, Boelig R, Leiby BE, Short V, Yogeshkumar S, Charantimath US, Somannavar MS, Mallapur AA, Pol R, Ramadurg U, Sangavi R, Peerapur BV, Banu N, Patil PS, Patil AP, Roy S, Vastrad P, Wallace D, Shah H, Goudar SS. RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study. Trials. 2023 Dec 20;24(1):818. doi: 10.1186/s13063-023-07740-z.
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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
3 sites 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 Neurodevelopmental Abnormality, run by Thomas Jefferson University at 3 sites 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 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Offspring hemoglobin (time frame: Birth). The study lists 5 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 NCT05504863, 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 29 Nov 2023.