Iron Deficiency (Without Anemia)NCT06990373
Iron Status of Non-anemic Pregnant Women in First Trimester
An observational study of Iron Deficiency (Without Anemia) and Reference Values, run by Hung Vuong Hospital at 1 site in Vietnam.
Trial summary
This cross-sectional study aims to establish reference intervals for iron biomarkers-including serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT)-in healthy pregnant women during the first trimester. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency (Without Anemia), Reference Values, Iron Deficiency Without Anemia
- How many people
- 600 participants
- Where
- 1 siteVietnam
- Study dates
- 12 Mar 2025to 30 Aug 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- Pregnant women attending antenatal care, carrying a single live fetus.
- Systolic blood pressure at the time of examination < 140 mmHg.
- Diastolic blood pressure at the time of examination < 90 mmHg.
- Body temperature at the time of examination between >35°C and <37.5°C.
- Hemoglobin ≥ 11 g/dL
Who cannot join
- History of diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic cancers, systemic lupus erythematosus, Gastrointestinal diseases (Celiac disease, Crohn's disease and ulcerative colitis, Gastric diseases or prior gastrointestinal surgery, Irritable bowel syndrome, etc).
- Currently on gastric acid-suppressing medications: Proton pump inhibitors (e.g., Omeprazole, Lansoprazole, Esomeprazole...), H2 receptor antagonists (e.g., Ranitidine, Famotidine, Cimetidine...), Positive screening for Treponema pallidum, HBsAg, or HIV.
- Use of stimulants or tobacco smoking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hung Vuong Hospital
Ho Chi Minh City, Ho Chi Minh, 70000
Nghiem Xuan Huynh, Medical doctor, +8402838558532, bv.hungvuong@tphcm.gov.vn
About this study
Official title: Establishment of Reference Intervals for Iron Test Panel for Pregnant Women at Hung Vuong Hospital
This cross-sectional study aims to establish reference intervals for iron biomarkers-including serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT)-in healthy pregnant women during the first trimester. Additionally, the study will investigate the current prevalence of non-anemic iron deficiency (NAID) in this population. By applying strict inclusion and exclusion criteria to eliminate potential confounding factors, the study seeks to provide a reliable baseline for evaluating iron status and early detection of iron deficiency without anemia among pregnant women.
Read the detailed description
- Title Reference Intervals of Iron, Ferritin, TIBC, and Transferrin Saturation in First Trimester Pregnant Women and Prevalence of Non-Anemic Iron Deficiency
- Background and Rationale Iron deficiency (ID) is the most common micronutrient deficiency globally and a significant concern during pregnancy. Early identification of iron deficiency-even in the absence of anemia-is essential to prevent adverse maternal and fetal outcomes. However, reference intervals for iron biomarkers in early pregnancy remain inconsistent and vary across populations. Moreover, there is a paucity of data on the prevalence of non-anemic iron deficiency (NAID) during the first trimester, a critical period for fetal development. This study aims to address these gaps.
- Objectives Primary Objective: To determine reference intervals for serum iron, ferritin, TIBC, and TSAT in healthy pregnant women during the first trimester. Secondary Objective: To estimate the prevalence of non-anemic iron deficiency (NAID), defined as low iron biomarkers with normal hemoglobin (Hb ≥ 11 g/dL).
- Study Design Type: Cross-sectional observational study Setting: Antenatal care clinics at Hung Vuong Hospital, Ho Chi Minh city, Vietnam Duration: From March to June, 2025 (anticipated)
- Study Population Inclusion Criteria
- Pregnant women in the first trimester (gestational age ≤ 13 weeks 6 days).
- Carrying a single live fetus.
- Hemoglobin ≥ 11 g/dL at the time of enrollment.
- Systolic blood pressure < 140 mmHg and diastolic < 90 mmHg.
- Body temperature > 35°C and < 37.5°C at time of examination.
- Attending routine antenatal care and willing to participate. Exclusion Criteria
- History of: Diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic malignancies, systemic lupus erythematosus. Gastrointestinal disorders affecting iron absorption (e.g., Celiac disease, Crohn's disease, ulcerative colitis, gastric surgery).
- Current use of acid-suppressing medications (PPIs, H2 blockers).
- Positive screening for Treponema pallidum, HBsAg, or HIV.
- Use of stimulants or tobacco smoking.
- Sample Size A minimum of 120 participants is recommended for establishing reference intervals per CLSI guidelines (C28-A3), with oversampling to account for exclusions and incomplete data.
- Data Collection Clinical Data
- Maternal age, gestational age, BMI
- Vital signs (BP, temperature)
- Medical and obstetric history Laboratory Investigations
- Hemoglobin (Hb)
- Serum iron
- Ferritin
- Total iron-binding capacity (TIBC)
- Transferrin saturation (TSAT) = (Serum iron / TIBC) × 100
- Statistical Analysis Reference Intervals
- Outlier detection using Dixon-Reed methods
- Calculation of 2.5th-97.5th percentiles (non-parametric method) Prevalence of NAID
- Defined as ferritin < 15 ng/mL or TSAT < 20% with Hb ≥ 11 g/dL (or more cutoffs to present a wide variety of prevalences of NAID). Reported as frequency and percentage with 95% confidence intervals Software
- Statistical analysis will be performed using Jupyter Notebook (python programming language)
- Ethical Considerations
- Ethical approval will be obtained from the Institutional Review Board.
- Written informed consent will be obtained from all participants.
- Data confidentiality will be strictly maintained.
- Significance The findings will provide local reference standards for iron parameters during early pregnancy and help clinicians better detect and manage iron deficiency before the onset of anemia. This is critical for optimizing maternal and fetal health outcomes and future study to determine best intervention for NAID patients.
- Keywords
- NAID, IDWA, Iron deficiency, Pregnant
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With iron supplement | Pregnant women who are taking iron supplement | |
| Without iron supplement | Pregnant women who are not taking any iron supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) < 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Measured: At baseline (upon enrollment)
Prevalence of non iron supplement using women that has non-anemic iron deficiency in the first trimester
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) < 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Measured: At baseline (upon enrollment)
Reference Intervals for Iron Biomarkers in the First Trimester
Establish reference intervals (2.5th-97.5th percentile) for serum iron, ferritin, TIBC, and TSAT in healthy first-trimester pregnant women meeting inclusion criteria
Measured: At baseline (upon enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start12 Mar 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency (Without Anemia)Studies 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hung Vuong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huan Nguyen Pham, Hung Vuong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990373
- Sponsor's protocol ID
- CS/HV/24/42
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, the investigators plan to share individual participant data (IPD) that underlie the results reported in future publications, including de-identified data on hemoglobin, serum iron, ferritin, TIBC, transferrin saturation (TSAT), maternal demographics (age, BMI, gestational age), and relevant inclusion/exclusion criteria. Data will be available upon reasonable request for research purposes, following approval by the principal investigator and ethics board, and under a data-sharing agreement to ensure confidentiality and appropriate use.
Publications
Auerbach M, Abernathy J, Juul S, Short V, Derman R. Prevalence of iron deficiency in first trimester, nonanemic pregnant women. J Matern Fetal Neonatal Med. 2021 Mar;34(6):1002-1005. doi: 10.1080/14767058.2019.1619690. Epub 2019 Jun 3.
PubMed 31154873Fisher AL, Nemeth E. Iron homeostasis during pregnancy. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1567S-1574S. doi: 10.3945/ajcn.117.155812. Epub 2017 Oct 25.
PubMed 29070542Daru J, Allotey J, Pena-Rosas JP, Khan KS. Serum ferritin thresholds for the diagnosis of iron deficiency in pregnancy: a systematic review. Transfus Med. 2017 Jun;27(3):167-174. doi: 10.1111/tme.12408. Epub 2017 Apr 20.
PubMed 28425182Mei Z, Addo OY, Jefferds MED, Flores-Ayala RC, Brittenham GM. Physiologically based trimester-specific serum ferritin thresholds for iron deficiency in US pregnant women. Blood Adv. 2024 Jul 23;8(14):3745-3753. doi: 10.1182/bloodadvances.2024013460.
PubMed 38781318Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
PubMed 33285139
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Reference Intervals for Iron Test Panel for Pregnant Women at Hung Vuong Hospital
- ClinicalTrials.gov ID
- NCT06990373
- Acronym / sponsor ID
- CS/HV/24/42
- Keywords
- NAID, IDWA, Iron deficiency, Pregnant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hung Vuong HospitalUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 25 May 2025 (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.
This cross-sectional study aims to establish reference intervals for iron biomarkers-including serum iron, ferritin, total iron-binding capacity (TIBC), and transferrin saturation (TSAT)-in healthy pregnant women during the first trimester. Additionally, the study will investigate the current prevalence of non-anemic iron deficiency (NAID) in this population. By applying strict inclusion and exclusion criteria to eliminate potential confounding factors, the study seeks to provide a reliable baseline for evaluating iron status and early detection of iron deficiency without anemia among pregnant women.
Detailed description
- Title Reference Intervals of Iron, Ferritin, TIBC, and Transferrin Saturation in First Trimester Pregnant Women and Prevalence of Non-Anemic Iron Deficiency
- Background and Rationale Iron deficiency (ID) is the most common micronutrient deficiency globally and a significant concern during pregnancy. Early identification of iron deficiency-even in the absence of anemia-is essential to prevent adverse maternal and fetal outcomes. However, reference intervals for iron biomarkers in early pregnancy remain inconsistent and vary across populations. Moreover, there is a paucity of data on the prevalence of non-anemic iron deficiency (NAID) during the first trimester, a critical period for fetal development. This study aims to address these gaps.
- Objectives Primary Objective: To determine reference intervals for serum iron, ferritin, TIBC, and TSAT in healthy pregnant women during the first trimester. Secondary Objective: To estimate the prevalence of non-anemic iron deficiency (NAID), defined as low iron biomarkers with normal hemoglobin (Hb ≥ 11 g/dL).
- Study Design Type: Cross-sectional observational study Setting: Antenatal care clinics at Hung Vuong Hospital, Ho Chi Minh city, Vietnam Duration: From March to June, 2025 (anticipated)
- Study Population Inclusion Criteria
- Pregnant women in the first trimester (gestational age ≤ 13 weeks 6 days).
- Carrying a single live fetus.
- Hemoglobin ≥ 11 g/dL at the time of enrollment.
- Systolic blood pressure < 140 mmHg and diastolic < 90 mmHg.
- Body temperature > 35°C and < 37.5°C at time of examination.
- Attending routine antenatal care and willing to participate. Exclusion Criteria
- History of: Diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic malignancies, systemic lupus erythematosus. Gastrointestinal disorders affecting iron absorption (e.g., Celiac disease, Crohn's disease, ulcerative colitis, gastric surgery).
- Current use of acid-suppressing medications (PPIs, H2 blockers).
- Positive screening for Treponema pallidum, HBsAg, or HIV.
- Use of stimulants or tobacco smoking.
- Sample Size A minimum of 120 participants is recommended for establishing reference intervals per CLSI guidelines (C28-A3), with oversampling to account for exclusions and incomplete data.
- Data Collection Clinical Data
- Maternal age, gestational age, BMI
- Vital signs (BP, temperature)
- Medical and obstetric history Laboratory Investigations
- Hemoglobin (Hb)
- Serum iron
- Ferritin
- Total iron-binding capacity (TIBC)
- Transferrin saturation (TSAT) = (Serum iron / TIBC) × 100
- Statistical Analysis Reference Intervals
- Outlier detection using Dixon-Reed methods
- Calculation of 2.5th-97.5th percentiles (non-parametric method) Prevalence of NAID
- Defined as ferritin < 15 ng/mL or TSAT < 20% with Hb ≥ 11 g/dL (or more cutoffs to present a wide variety of prevalences of NAID). Reported as frequency and percentage with 95% confidence intervals Software
- Statistical analysis will be performed using Jupyter Notebook (python programming language)
- Ethical Considerations
- Ethical approval will be obtained from the Institutional Review Board.
- Written informed consent will be obtained from all participants.
- Data confidentiality will be strictly maintained.
- Significance The findings will provide local reference standards for iron parameters during early pregnancy and help clinicians better detect and manage iron deficiency before the onset of anemia. This is critical for optimizing maternal and fetal health outcomes and future study to determine best intervention for NAID patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With iron supplement | – | –Pregnant women who are taking iron supplement |
| Without iron supplement | – | –Pregnant women who are not taking any iron supplement |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- Pregnant women attending antenatal care, carrying a single live fetus.
- Systolic blood pressure at the time of examination < 140 mmHg.
- Diastolic blood pressure at the time of examination < 90 mmHg.
- Body temperature at the time of examination between >35°C and <37.5°C.
- Hemoglobin ≥ 11 g/dL
Key exclusion criteria (3 listed)
- History of diabetes mellitus, hypertension, hemoglobinopathies, leukemia, non-hematologic cancers, systemic lupus erythematosus, Gastrointestinal diseases (Celiac disease, Crohn's disease and ulcerative colitis, Gastric diseases or prior gastrointestinal surgery, Irritable bowel syndrome, etc).
- Currently on gastric acid-suppressing medications: Proton pump inhibitors (e.g., Omeprazole, Lansoprazole, Esomeprazole...), H2 receptor antagonists (e.g., Ranitidine, Famotidine, Cimetidine...), Positive screening for Treponema pallidum, HBsAg, or HIV.
- Use of stimulants or tobacco smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester
Time frame: At baseline (upon enrollment)
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) < 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Prevalence of non iron supplement using women that has non-anemic iron deficiency in the first trimester
Time frame: At baseline (upon enrollment)
Non-anemic iron deficiency is defined as hemoglobin ≥ 11 g/dL and transferrin saturation (TSAT) < 20%. The prevalence will be calculated as the proportion of enrolled pregnant women meeting these criteria
Reference Intervals for Iron Biomarkers in the First Trimester
Time frame: At baseline (upon enrollment)
Establish reference intervals (2.5th-97.5th percentile) for serum iron, ferritin, TIBC, and TSAT in healthy first-trimester pregnant women meeting inclusion criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 31154873Auerbach M, Abernathy J, Juul S, Short V, Derman R. Prevalence of iron deficiency in first trimester, nonanemic pregnant women. J Matern Fetal Neonatal Med. 2021 Mar;34(6):1002-1005. doi: 10.1080/14767058.2019.1619690. Epub 2019 Jun 3.
- Background: PubMed 29070542Fisher AL, Nemeth E. Iron homeostasis during pregnancy. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1567S-1574S. doi: 10.3945/ajcn.117.155812. Epub 2017 Oct 25.
- Background: PubMed 28425182Daru J, Allotey J, Pena-Rosas JP, Khan KS. Serum ferritin thresholds for the diagnosis of iron deficiency in pregnancy: a systematic review. Transfus Med. 2017 Jun;27(3):167-174. doi: 10.1111/tme.12408. Epub 2017 Apr 20.
- Background: PubMed 38781318Mei Z, Addo OY, Jefferds MED, Flores-Ayala RC, Brittenham GM. Physiologically based trimester-specific serum ferritin thresholds for iron deficiency in US pregnant women. Blood Adv. 2024 Jul 23;8(14):3745-3753. doi: 10.1182/bloodadvances.2024013460.
- Background: PubMed 33285139Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
- Individual participant dataSharing planned: Yes. Yes, the investigators plan to share individual participant data (IPD) that underlie the results reported in future publications, including de-identified data on hemoglobin, serum iron, ferritin, TIBC, transferrin saturation (TSAT), maternal demographics (age, BMI, gestational age), and relevant inclusion/exclusion criteria. Data will be available upon reasonable request for research purposes, following approval by the principal investigator and ethics board, and under a data-sharing agreement to ensure confidentiality and appropriate use.
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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.
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 (Without Anemia) and Reference Values, run by Hung Vuong Hospital at 1 site in Vietnam.
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 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: looking for participants now, as of the sponsor's last update on 30 May 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huan Nguyen Pham, Master of medicine (+849068844435, huanpmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of iron supplement using women that has non-anemic iron deficiency in the first trimester (time frame: At baseline (upon enrollment)). 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?
On the ClinicalTrials.gov record for NCT06990373, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.