Health TrialsbyHealthPanel

Oral Iron Supplementation on Alternate vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

ConditionsIron-deficiency Anemia (IDA)Pregnancy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSouthern Illinois University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • daily ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill

    Drug

    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 pill

    Drug

    ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: 1) Daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillExperimental treatment 1 intervention
Group B: 2) Alternate daily dose of ferrous sulfate with an equivalent elemental iron dose of 65 mg per pillExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

reversal of iron deficient anemia

hemoglobin \> 10.5 g/dL

Time frame
8 weeks after the baseline visit ± 7 days
2

reversal of iron deficient anemia

ferritin \> 15 mcg/L

Time frame
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

Time frame
8 weeks after the baseline visit ± 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southern Illinois University

Lead sponsor

Source ClinicalTrials.gov
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