Iron-deficiency Anemia (IDA), Pregnancy
Conditions
Keywords
Iron-deficiency anemia (IDA), Iron-deficiency anemia (IDA) during gestation
Brief 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.
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
DRUGdaily 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
DRUGalternate 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
Sponsors
Southern Illinois University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized 1:1 for daily iron (ferrous sulfate) supplementation vs. every other day iron (ferrous sulfate) supplementation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reversal of iron deficient anemia | 8 weeks after the baseline visit ± 7 days | hemoglobin \> 10.5 g/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| soluble transferrin receptor (sTfR) levels within normal range | 8 weeks after the baseline visit ± 7 days | 1.8-4.6 mg/L |
Countries
United States
Contacts
CONTACTKathleen A Groesch, MS
CONTACTTeresa S Wilson, BA
PRINCIPAL_INVESTIGATORYahia Zeino, MD
Southern Illinois University School of Medicine
Outcome results
None listed