Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and
      the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are
      serious and can include diminished intellectual and productive capacity and possibly
      increased susceptibility to infection in mothers and infants, low birthweight, and premature
      births, hence the importance of appropriate treatment during pregnancy.

      Most guidelines recommend an increase in iron consumption by about 15-30 mg/day, an amount
      readily met by most prenatal vitamin formulations. This is adequate supplementation for
      non-anemic and non-iron-deficient women. However, women with iron deficiency anemia should
      receive an additional 30-20 mg/day until the anemia is corrected.

      It is not clear whether intermittent administration of oral iron is equivalent to once daily
      to rise the hemoglobin levels in pregnant women with iron deficiency anemia. Alternate day
      treatment with supplemental iron has been suggested as a way to improve its absorption
      because daily doses may suppress the mucosal uptake of iron even in the presence of iron
      deficiency until the intestinal mucosa completes its turnover.

      Another possible factor associated with the frequency of iron dosing is related to hepcidin,
      the central regulatory molecule in the metabolism of iron in mammals. The synthesis of
      hepcidin is controlled by 3 kinds of signals: inflammation; the need for increased
      erythropoiesis, and an iron status signal based on plasma iron levels and iron stores. If
      plasma iron levels or iron stores are increased, the resulting signal increases hepcidin
      levels, thereby blocking iron absorption and its release from stores (liver, macrophages) and
      preventing iron overload.This hepcidin effect, suppressing iron absorption, could last as
      long as 48h.

      In this study, the researchers aim to determine if alternate day dosing of iron in pregnant
      women with iron deficiency anemia results in improved levels of hemoglobin or hematocrit and
      ferritin.

      Hepcidin levels will be compared between patients on daily iron supplementation versus
      alternate day supplementation.

      The researchers will also evaluate if alternate day dosing of iron supplementation results in
      a better side effect profile, and with better patient compliance.
    


Intervention name(s): Ferrous Sulfate; Ferrous Sulfate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.; Patients will take iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) daily for 6 weeks.
Other intervention name(s): Alternate-day iron supplementation; Daily iron supplementation
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients that agree to participate will be randomized to receive either 1 tablet of 325mg ferrous sulfate (65 mg of elemental iron) on consecutive days for 6 weeks or 2 tablets together (130 mg of elemental iron ) every other day for 6 weeks. Both groups will be receiving the same total amount of iron over the study period (2730 mg of elemental iron over 6 weeks).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron; Deficiency; Anemia; Supplementation; Pregnancy