Daily vs Intermittent Iron Therapy in Pregnancy
Condition: Iron Deficiency Anemia of Pregnancy
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      This is a randomized non inferiority trial to evaluate the response to iron therapy in the
      standard daily vs. intermittent (three-four times a week on nonconsecutive days) groups by
      using hematological markers (hemoglobin, hematocrit, transferrin, hepcidin, ferritin, human
      soluble transferrin receptor). The secondary outcome is to evaluate gastrointestinal
      discomfort and adherence to therapy between two treatment groups.
    

Detailed description: 
      The Centers for Disease Control and Prevention estimates that as many as 8 million American
      women of childbearing age are iron deficient. In a typical singleton gestation, the maternal
      need for iron averages close to 1000 mg. Of this 300 mg is for the fetus and placenta; 500 mg
      for maternal hemoglobin mass expansion; and 200 mg that is normally shed through the gut,
      urine, and skin. The total amount of 1000 mg considerably exceeds the iron stores of most
      women and results in iron-deficiency anemia unless iron supplementation is given.

      Correction of anemia and restitution of iron stores can be accomplished with simple iron
      compounds-ferrous sulfate, fumarate or gluconate. Oral iron is an effective treatment for
      iron deficiency anemia and is inexpensive, safe and widely available.

      In the past, a standard approach to the treatment of iron deficiency anemia was oral ferrous
      sulfate 325 mg (65 mg elemental iron) spaced in 3 doses each day for a total daily dose of
      195 mg elemental iron. However, recent absorption studies concluded that maximal absorption
      of iron occurs with a dose in the range of 40 to 80 mg of elemental iron daily. This study
      was done in non pregnant iron-deficient women. Greater doses do not result in more iron
      absorption and are associated with more side effects. The findings of this study have been
      implemented by many into various areas of medicine.

      Daily oral supplementation in pregnant women has been a long-standing, cost-effective
      recommended intervention both in the public health and clinical fields. However, adherence to
      daily iron and folic acid supplementation still faces challenges. Data from national surveys
      from 46 countries (2003 to 2009) indicate that about 52% to 75% of mothers receive any iron
      tablets during pregnancy, and the duration of supplementation is usually short.

      According to a study by Khalafallah, the side effects or oral iron therapy including
      gastrointestinal disturbances characterized by colicky pain, nausea, vomiting, diarrhea, and
      constipation occur in about 50% of a patient taking iron preparations, and the investigators
      estimate that their patients have similar complaints and intolerances.

      Many pregnant women taking oral iron, especially at doses greater than 30 mg daily of
      elemental iron daily, have gastrointestinal side effects, which cause them to discontinue the
      iron therapy. Taking iron supplementation on an intermittent basis may help to reduce
      gastrointestinal side effects and improve iron stores.

      In the United States, the oral iron preparation of ferrous sulfate is often used to replete
      iron-deficient women. To the investigators' knowledge, studies have not been performed to
      evaluate daily vs. oral intermittent oral iron therapy in the United States, which has a
      different nutritional status and access to health care than other countries.

      This study will randomize patients to the standard therapy: taking iron ferrous sulfate 325
      mg (daily) by mouth once a day by mouth or intermittent therapy of taking ferrous sulfate 325
      mg three- four times a week on alternating days. Hematological markers (hemoglobin,
      hematocrit, transferrin, hepcidin, ferritin, human soluble transferrin receptor), will be
      assessed prior to treatment and after treatment is completed.
    

Intervention name(s): Ferrous Sulfate
Intervention type(s): Dietary Supplement
Intervention description(s): Patients would be randomized to either taking ferrous sulfate daily or every other day (on non consecutive days).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Noninferiority Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron Deficiency Anemia; Pregnancy; Side Effects