Iron Supplement to Improve Iron Status Following Bariatric Surgery
Condition: Anemia, Iron Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and
      effective therapies are lacking. Thus, there is a critical need for an effective,
      non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and
      improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric
      surgery patient population. Often, patients do not participate in bariatric programs, are not
      compliant, and/or are lost to follow-up. If there is a more effective and evidence-based
      guideline for repletion of iron deficiency, patients are more likely to be compliant.
      Therefore, in a randomized controlled study, the investigators propose to test the
      effectiveness of various iron formulations versus ferrous sulfate, which is the standard of
      care, for oral iron supplementation of iron deficient patients who have had RYGB or SG
      bariatric surgery. By randomizing patients into the two groups, the investigators will be
      able to determine the most effective regimen to improve blood biomarkers of iron status,
      cognitive function, and quality of life. Other outcomes will include adverse effects and
      compliance to the supplementation. The investigators will also analyze three-day food records
      to determine the contribution of dietary factors to changes in iron status. To test for
      improvement of iron status, serial blood draws will be performed during a time period of ~10
      weeks. Serial blood draws from iron deficient patients have routinely been performed in past
      studies and have not been found to be harmful. Because this is a relatively short study (10
      weeks), subjects will be able to recover quickly from the blood loss during the study. The
      investigators expect to find that iron supplementation with organic formulations of iron will
      be as effective than ferrous sulfate for repletion of iron deficiency, and they will be
      better tolerated. This project will address a significant health issue in individuals who
      have had bariatric surgery, which is a growing population in the United States. It is
      estimated that almost 1.5 million individuals have undergone bariatric surgery since the year
      1990.
    

Detailed description: 
      Objectives:

        1. To determine the most effective oral iron supplementation regimen for repletion of iron
           deficiency in patients who have had gastric bypass or sleeve gastrectomy. In iron
           deficient patients, two supplement regimens will be compared:

             1. Ferrous sulfate 65 mg t.i.d. (standard of care / control), which is elemental iron

             2. AspironTM, which is an organic formulation of iron

           Primary outcomes will be reference indices of iron status:

             -  Ferritin, TIBC, sTfR, and sTfR:ferritin ratio

             -  Secondary outcomes will be:

             -  measures of anemia, determined by blood hemoglobin concentrations

             -  measures of cognitive function via several computerized tests on working memory,
                sustained attention, and spatial memory

             -  fatigue by Multidimensional Fatigue Inventory questionnaire

             -  Quality of life by SF-36 Survey

           Safety outcomes will be:

           • adverse events, compliance, measures of iron toxicity, and liver enzymes

        2. In the same subjects undergoing iron supplementation described in Aim 1, to determine
           the contribution of dietary factors (including heme and non-heme iron intake, and intake
           of enhancers and inhibitors of iron absorption) to changes in iron status.
    

Intervention name(s): Oral iron supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will be provided supplementation for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: iron deficiency; sleeve gastrectomy; gastric bypass; bariatric surgery