Iron-deficiency Anemia (IDA)Phase 4NCT06492512
Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
A Phase 4 study testing daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill and alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill in people with Iron-deficiency Anemia (IDA) and Pregnancy, run by Southern Illinois University at 1 site in United States.
Trial summary
This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron-deficiency Anemia (IDA), Pregnancy
- What is being tested?
- daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill and alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to 30 Jul 2029
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L)
Who cannot join
- Patients <18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Amber Fifer, Pharm D, 217-545-4541, afifer56@siumed.edu
Yahia Zeino, MD
About this study
This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.
Read the detailed description
During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.
- Conditions
- Iron-deficiency Anemia (IDA), Pregnancy
- Being tested
- daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill, alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
- Keywords
- Iron-deficiency anemia (IDA), Iron-deficiency anemia (IDA) during gestation
- 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.
daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillDrug
Also called daily
ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily
alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillDrug
Also called alternate day
ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day
| Study group | Role | What they receive |
|---|---|---|
| 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Experimental | daily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill Receives: Drug: daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
| 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Experimental | alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill Receives: Drug: alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
reversal of iron deficient anemia
hemoglobin > 10.5 g/dL
Measured: 8 weeks after the baseline visit ± 7 days
reversal of iron deficient anemia
ferritin > 15 mcg/L
Measured: 8 weeks after the baseline visit ± 7 days
Secondary outcomes (1)
soluble transferrin receptor (sTfR) levels within normal range
1.8-4.6 mg/L
Measured: 8 weeks after the baseline visit ± 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start27 May 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiency Anemia (IDA)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 for daily iron (ferrous sulfate) supplementation vs. every other day iron (ferrous sulfate) supplementation
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yahia Zeino, MD, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492512
- Sponsor's protocol ID
- 21-924
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
- ClinicalTrials.gov ID
- NCT06492512
- Acronym / sponsor ID
- 21-924
- Conditions
- Iron-deficiency Anemia (IDA), Pregnancy
- Keywords
- Iron-deficiency anemia (IDA), Iron-deficiency anemia (IDA) during gestation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- 27 May 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 9 Jul 2024 (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 will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.
Detailed description
During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 for daily iron (ferrous sulfate) supplementation vs. every other day iron (ferrous sulfate) supplementation
| Arm | Type | Receives |
|---|---|---|
| 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Experimental | Drug: daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pilldaily (Group 1) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
| 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill | Experimental | Drug: alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillalternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L)
Key exclusion criteria (1 listed)
- Patients <18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)
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 |
|---|---|---|
| daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillAlso: dailyferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily | Drug | 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
| alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillAlso: alternate dayferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day | Drug | 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill |
Primary outcome
reversal of iron deficient anemia
Time frame: 8 weeks after the baseline visit ± 7 days
hemoglobin > 10.5 g/dL
reversal of iron deficient anemia
Time frame: 8 weeks after the baseline visit ± 7 days
ferritin > 15 mcg/L
1 secondary outcome
soluble transferrin receptor (sTfR) levels within normal range
Time frame: 8 weeks after the baseline visit ± 7 days
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 24 Apr 2026.
- 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.
Yahia Zeino, MD principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill and alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill in people with Iron-deficiency Anemia (IDA) and Pregnancy, run by Southern Illinois University at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kathleen A Groesch, MS (217-545-6671, kgroesch@siumed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reversal of iron deficient anemia (time frame: 8 weeks after the baseline visit ± 7 days). The study lists 2 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 24 Apr 2026.