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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill daily
ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill every other day
Southern Illinois University School of Medicine
Springfield, Illinois, United States
RECRUITINGreversal of iron deficient anemia
hemoglobin \> 10.5 g/dL
Time frame: 8 weeks after the baseline visit ± 7 days
reversal of iron deficient anemia
ferritin \> 15 mcg/L
Time frame: 8 weeks after the baseline visit ± 7 days
soluble transferrin receptor (sTfR) levels within normal range
1.8-4.6 mg/L
Time frame: 8 weeks after the baseline visit ± 7 days
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