Iron RequirementsPILLAR_IINCT05973552
Iron Absorption and Requirements in Pregnancy and Lactation
An observational study of Iron Requirements and Pregnancy, run by University of Oxford at 1 site in Kenya.
Trial summary
Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Requirements, Pregnancy, Lactation
- What is being tested?
- CO-rebreathing, Oral iron isotope administration (54Fe) and Intravenous iron isotope administration (58Fe)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteKenya
- Study dates
- 31 Jul 2023to 1 Sep 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will recruit 250 pregnant women in the first trimester who previously participated in a stable iron isotope study (Clinical Trial ID: NCT05266703) and received 15 mg of the stable iron isotope 57Fe as an oral dose of ferrous sulphate at least 12 months before being enrolled in this trial.
Who may be able to join
- Providing consent to the informed consent form
- Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
- Positive pregnancy test and gestational age <10 weeks based on history of last menstrual period
- Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
- Assessment of good health by professional staff at Msambweni Hospital
Who cannot join
- Pre-pregnancy body mass index >30 kg/m2
- Blood transfusion or intravenous iron treatment within 4 months of study start
- Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
- Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Msambweni Referral Hospital
Msambweni
Edith Mwasi, MD
About this study
Official title: Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.
The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.
In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.
- Conditions
- Iron Requirements, Pregnancy, Lactation, Infancy, Iron Absorption
- Being tested
- CO-rebreathing, Oral iron isotope administration (54Fe), Intravenous iron isotope administration (58Fe)
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-rebreathingOther
In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume
Oral iron isotope administration (54Fe)Other
Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption
Intravenous iron isotope administration (58Fe)Other
Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation
| Study group | Role | What they receive |
|---|---|---|
| All participants | Women (n=250), are followed throughout their pregnancy. Mother-infant pairs are followed throughout the first 6-months postpartum. Women receive daily oral iron supplementation during pregnancy in accordance with local standards of care. Using the stable iron isotopes dilution methodology, concentration of the stable iron isotope tracer (57Fe) in circulation will be measured throughout pregnancy and up to 6 months postpartum in both, mother and infant. Receives: Other: CO-rebreathing | |
| Randomly selected sub-group | To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered. Oral iron absorption and erythrocyte iron incorporation will be measured 14 days after tracer administration. Receives: Other: CO-rebreathing; Other: Oral iron isotope administration (54Fe); Other: Intravenous iron isotope administration (58Fe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorbed, lossed and gained in the first trimester
isotope dilution
Measured: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
Iron absorbed, lossed and gained in the second trimester
isotope dilution
Measured: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
Iron absorbed, lossed and gained in the third trimester
isotope dilution
Measured: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
Iron absorbed, lossed and gained throughout pregnancy
isotope dilution
Measured: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
Iron absorbed, lossed and gained in lactating women
isotope dilution
Measured: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
Iron absorbed, lossed and gained in infancy
isotope dilution
Measured: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
Secondary outcomes (102)
Fractional iron absorption (%) in the second trimester
shift in iron isotopic ratios
Measured: gestational age 20 weeks
Fractional iron absorption (%) in the third trimester
shift in iron isotopic ratios
Measured: gestational age 30 weeks
Erythrocyte iron incorporation (%) in the second trimester
shift in iron isotopic ratios
Measured: gestational age 20 weeks
Erythrocyte iron incorporation (%) in the third trimester
shift in iron isotopic ratios
Measured: gestational age 30 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 6 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 10 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 15 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 20 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 25 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 30 weeks
Hemoglobin concentration (g/dl)
Hb
Measured: gestational age 36 weeks
Hemoglobin concentration (g/dl)
mother
Measured: 6 weeks postpartum
Hemoglobin concentration (g/dl)
infant
Measured: age 6 weeks
Hemoglobin concentration (g/dl)
mother
Measured: 14 weeks postpartum
Hemoglobin concentration (g/dl)
infant
Measured: age 14 weeks
Hemoglobin concentration (g/dl)
mother
Measured: 24 weeks postpartum
Hemoglobin concentration (g/dl)
infant
Measured: age 24 weeks
Mean corpuscular volume (fl)
MCV
Measured: gestational age 6 weeks
Mean corpuscular volume (fl)
MCV
Measured: gestational age 10 weeks
Mean corpuscular volume (fl)
MCV
Measured: gestational age 20 weeks
Mean corpuscular volume (fl)
MCV
Measured: gestational age 30 weeks
Mean corpuscular volume (fl)
mother
Measured: 6 weeks postpartum
Mean corpuscular volume (fl)
infant
Measured: age 6 weeks
Mean corpuscular volume (fl)
mother
Measured: 14 weeks postpartum
Mean corpuscular volume (fl)
infant
Measured: age 14 weeks
Mean corpuscular volume (fl)
mother
Measured: 24 weeks postpartum
Mean corpuscular volume (fl)
infant
Measured: age 24 weeks
Erythropoietin concentration (mU/ml)
EPO
Measured: gestational age 10 weeks
Erythropoietin concentration (mU/ml)
EPO
Measured: gestational age 20 weeks
Erythropoietin concentration (mU/ml)
EPO
Measured: gestational age 30 weeks
Erythropoietin concentration (mU/ml)
EPO
Measured: 6 weeks postpartum
Erythropoietin concentration (mU/ml)
EPO
Measured: 14 weeks postpartum
Erythropoietin concentration (mU/ml)
EPO
Measured: 24 weeks postpartum
Erythroferrone concentration (ng/ml)
ERFE
Measured: gestational age 10 weeks
Erythroferrone concentration (ng/ml)
ERFE
Measured: gestational age 20 weeks
Erythroferrone concentration (ng/ml)
ERFE
Measured: gestational age 30 weeks
Erythroferrone concentration (ng/ml)
ERFE
Measured: 6 weeks postpartum
Erythroferrone concentration (ng/ml)
ERFE
Measured: 14 weeks postpartum
Erythroferrone concentration (ng/ml)
ERFE
Measured: 24 weeks postpartum
Hepcidin concentration (ng/ml)
Hep
Measured: gestational age 10 weeks
Hepcidin concentration (ng/ml)
Hep
Measured: gestational age 20 weeks
Hepcidin concentration (ng/ml)
Hep
Measured: gestational age 30 weeks
Hepcidin concentration (ng/ml)
Hep
Measured: 6 weeks postpartum
Hepcidin concentration (ng/ml)
Hep
Measured: 14 weeks postpartum
Hepcidin concentration (ng/ml)
Hep
Measured: 24 weeks postpartum
Serum ferritin concentration (ug/l)
SF
Measured: gestational age 10 weeks
Serum ferritin concentration (ug/l)
SF
Measured: gestational age 20 weeks
Serum ferritin concentration (ug/l)
SF
Measured: gestational age 30 weeks
Serum ferritin concentration (ug/l)
mother
Measured: 6 weeks postpartum
Serum ferritin concentration (ug/l)
infant
Measured: age 6 weeks
Serum ferritin concentration (ug/l)
mother
Measured: 14 weeks postpartum
Serum ferritin concentration (ug/l)
infant
Measured: age 14 weeks
Serum ferritin concentration (ug/l)
mother
Measured: 24 weeks postpartum
Serum ferritin concentration (ug/l)
infant
Measured: age 24 weeks
Soluble transferrin receptor concentration (ul/l)
sTfR
Measured: gestational age 10 weeks
Soluble transferrin receptor concentration (ul/l)
sTfR
Measured: gestational age 20 weeks
Soluble transferrin receptor concentration (ul/l)
sTfR
Measured: gestational age 30 weeks
Soluble transferrin receptor concentration (ul/l)
mother
Measured: 6 weeks postpartum
Soluble transferrin receptor concentration (ul/l)
infant
Measured: age 6 weeks
Soluble transferrin receptor concentration (ul/l)
mother
Measured: 14 weeks postpartum
Soluble transferrin receptor concentration (ul/l)
infant
Measured: age 14 weeks
Soluble transferrin receptor concentration (ul/l)
mother
Measured: 24 weeks postpartum
Soluble transferrin receptor concentration (ul/l)
infant
Measured: age 24 weeks
C-reactive protein concentration (mg/l)
CRP
Measured: gestational age 10 weeks
C-reactive protein concentration (mg/l)
CRP
Measured: gestational age 20 weeks
C-reactive protein concentration (mg/l)
CRP
Measured: gestational age 30 weeks
C-reactive protein concentration (mg/l)
mother
Measured: 6 weeks postpartum
C-reactive protein concentration (mg/l)
infant
Measured: age 6 weeks
C-reactive protein concentration (mg/l)
mother
Measured: 14 weeks postpartum
C-reactive protein concentration (mg/l)
infant
Measured: age 14 weeks
C-reactive protein concentration (mg/l)
mother
Measured: 24 weeks postpartum
C-reactive protein concentration (mg/l)
infant
Measured: age 24 weeks
alpha-glycoprotein concentration (mg/dl)
AGP
Measured: gestational age 10 weeks
alpha-glycoprotein concentration (mg/dl)
AGP
Measured: gestational age 20 weeks
alpha-glycoprotein concentration (mg/dl)
AGP
Measured: gestational age 30 weeks
alpha-glycoprotein concentration (mg/dl)
mother
Measured: 6 weeks postpartum
alpha-glycoprotein concentration (mg/dl)
infant
Measured: age 6 weeks
alpha-glycoprotein concentration (mg/dl)
mother
Measured: 14 weeks postpartum
alpha-glycoprotein concentration (mg/dl)
infant
Measured: age 14 weeks
alpha-glycoprotein concentration (mg/dl)
mother
Measured: 24 weeks postpartum
alpha-glycoprotein concentration (mg/dl)
infant
Measured: age 24 weeks
Blood volume (l)
Measured: gestational age 10 weeks
Blood volume (l)
BV
Measured: gestational age 20 weeks
Blood volume (l)
BV
Measured: gestational age 30 weeks
Blood volume (l)
BV
Measured: 6 weeks postpartum
Blood volume (l)
BV
Measured: 14 weeks postpartum
Blood volume (l)
BV
Measured: 24 weeks postpartum
Intestinal fatty acid binding protein
I-FABP
Measured: gestational age 10 weeks
Intestinal fatty acid binding protein
I-FABP
Measured: gestational age 20 weeks
Intestinal fatty acid binding protein
I-FABP
Measured: gestational age 30 weeks
Retinol binding protein
RBP
Measured: gestational age 10 weeks
Retinol binding protein
RBP
Measured: gestational age 20 weeks
Retinol binding protein
RBP
Measured: gestational age 30 weeks
soluble CD14
sCD14
Measured: gestational age 10 weeks
soluble CD14
sCD14
Measured: gestational age 20 weeks
soluble CD14
sCD14
Measured: gestational age 30 weeks
Insulin-like growth factor 1
IGF-1
Measured: gestational age 10 weeks
Insulin-like growth factor 1
IGF-1
Measured: gestational age 20 weeks
Insulin-like growth factor 1
IGF-1
Measured: gestational age 30 weeks
Fibroblast growth factor 21
FGF21
Measured: gestational age 10 weeks
Fibroblast growth factor 21
FGF21
Measured: gestational age 20 weeks
Fibroblast growth factor 21
FGF21
Measured: gestational age 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start31 Jul 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron RequirementsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Jomo Kenyatta University of Agriculture and Technology, Msambweni County Referral Hospital, ETH Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973552
- Sponsor's protocol ID
- PILLAR_II
- Acronym
- PILLAR_II
- Status last verified
- Jun 2023
- First submitted
- 18 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women
- ClinicalTrials.gov ID
- NCT05973552
- Acronym / sponsor ID
- PILLAR_II / PILLAR_II
- Conditions
- Iron Requirements, Pregnancy, Lactation, Infancy, Iron Absorption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Columbia University, Jomo Kenyatta University of Agriculture and Technology, Msambweni County Referral Hospital, ETH Zurich
- Study start
- 31 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Aug 2023 (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 requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.
The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.
In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: CO-rebreathingWomen (n=250), are followed throughout their pregnancy. Mother-infant pairs are followed throughout the first 6-months postpartum. Women receive daily oral iron supplementation during pregnancy in accordance with local standards of care. Using the stable iron isotopes dilution methodology, concentration of the stable iron isotope tracer (57Fe) in circulation will be measured throughout pregnancy and up to 6 months postpartum in both, mother and infant. |
| Randomly selected sub-group | – | Other: CO-rebreathing, Other: Oral iron isotope administration (54Fe), Other: Intravenous iron isotope administration (58Fe)To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered. Oral iron absorption and erythrocyte iron incorporation will be measured 14 days after tracer administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will recruit 250 pregnant women in the first trimester who previously participated in a stable iron isotope study (Clinical Trial ID: NCT05266703) and received 15 mg of the stable iron isotope 57Fe as an oral dose of ferrous sulphate at least 12 months before being enrolled in this trial.
Key inclusion criteria (5 listed)
- Providing consent to the informed consent form
- Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
- Positive pregnancy test and gestational age <10 weeks based on history of last menstrual period
- Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
- Assessment of good health by professional staff at Msambweni Hospital
Key exclusion criteria (4 listed)
- Pre-pregnancy body mass index >30 kg/m2
- Blood transfusion or intravenous iron treatment within 4 months of study start
- Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
- Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
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 |
|---|---|---|
| CO-rebreathingIn the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume | Other | All participants, Randomly selected sub-group |
| Oral iron isotope administration (54Fe)Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption | Other | Randomly selected sub-group |
| Intravenous iron isotope administration (58Fe)Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation | Other | Randomly selected sub-group |
Primary outcome
Iron absorbed, lossed and gained in the first trimester
Time frame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks
isotope dilution
Iron absorbed, lossed and gained in the second trimester
Time frame: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks
isotope dilution
Iron absorbed, lossed and gained in the third trimester
Time frame: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks
isotope dilution
Iron absorbed, lossed and gained throughout pregnancy
Time frame: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks
isotope dilution
Iron absorbed, lossed and gained in lactating women
Time frame: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum
isotope dilution
Iron absorbed, lossed and gained in infancy
Time frame: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks
isotope dilution
102 secondary outcomes
Fractional iron absorption (%) in the second trimester
Time frame: gestational age 20 weeks
Fractional iron absorption (%) in the third trimester
Time frame: gestational age 30 weeks
Erythrocyte iron incorporation (%) in the second trimester
Time frame: gestational age 20 weeks
Erythrocyte iron incorporation (%) in the third trimester
Time frame: gestational age 30 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 6 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 10 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 15 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 20 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 25 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 30 weeks
Hemoglobin concentration (g/dl)
Time frame: gestational age 36 weeks
Hemoglobin concentration (g/dl)
Time frame: 6 weeks postpartum
Hemoglobin concentration (g/dl)
Time frame: age 6 weeks
Hemoglobin concentration (g/dl)
Time frame: 14 weeks postpartum
Hemoglobin concentration (g/dl)
Time frame: age 14 weeks
Hemoglobin concentration (g/dl)
Time frame: 24 weeks postpartum
Hemoglobin concentration (g/dl)
Time frame: age 24 weeks
Mean corpuscular volume (fl)
Time frame: gestational age 6 weeks
Mean corpuscular volume (fl)
Time frame: gestational age 10 weeks
Mean corpuscular volume (fl)
Time frame: gestational age 20 weeks
Mean corpuscular volume (fl)
Time frame: gestational age 30 weeks
Mean corpuscular volume (fl)
Time frame: 6 weeks postpartum
Mean corpuscular volume (fl)
Time frame: age 6 weeks
Mean corpuscular volume (fl)
Time frame: 14 weeks postpartum
Mean corpuscular volume (fl)
Time frame: age 14 weeks
Mean corpuscular volume (fl)
Time frame: 24 weeks postpartum
Mean corpuscular volume (fl)
Time frame: age 24 weeks
Erythropoietin concentration (mU/ml)
Time frame: gestational age 10 weeks
Erythropoietin concentration (mU/ml)
Time frame: gestational age 20 weeks
Erythropoietin concentration (mU/ml)
Time frame: gestational age 30 weeks
Erythropoietin concentration (mU/ml)
Time frame: 6 weeks postpartum
Erythropoietin concentration (mU/ml)
Time frame: 14 weeks postpartum
Erythropoietin concentration (mU/ml)
Time frame: 24 weeks postpartum
Erythroferrone concentration (ng/ml)
Time frame: gestational age 10 weeks
Erythroferrone concentration (ng/ml)
Time frame: gestational age 20 weeks
Erythroferrone concentration (ng/ml)
Time frame: gestational age 30 weeks
Erythroferrone concentration (ng/ml)
Time frame: 6 weeks postpartum
Erythroferrone concentration (ng/ml)
Time frame: 14 weeks postpartum
Erythroferrone concentration (ng/ml)
Time frame: 24 weeks postpartum
Hepcidin concentration (ng/ml)
Time frame: gestational age 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- 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.
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 Requirements and Pregnancy, run by University of Oxford at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 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 3 Aug 2023. 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 Kenya. 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?
Contact Nicole Stoffel, PhD (+41446328393, nicole.stoffel@rdm.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron absorbed, lossed and gained in the first trimester (time frame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks). The study lists 6 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 3 Aug 2023.