Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Iron-deficiency Anemia (IDA), Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily - Drug alternate day ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill
ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day
Primary outcome measures
- reversal of iron deficient anemia [Time frame: 8 weeks after the baseline visit ± 7 days]
- reversal of iron deficient anemia [Time frame: 8 weeks after the baseline visit ± 7 days]
Secondary outcome measures (1)
- soluble transferrin receptor (sTfR) levels within normal range [Time frame: 8 weeks after the baseline visit ± 7 days]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Southern Illinois University School of Medicine — Springfield
Identifiers
NCT: NCT06492512 · 21-924