Impact of Host Iron Status and Iron Supplement Use on Erythrocytic Stage of Plasmodium Falciparum
Condition: Iron Deficiency Anemia; Malaria
MeSH terms: Malaria; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The purpose of this study is to perform laboratory based studies to determine if the growth
      and development of the malaria parasite is effected by iron status of its host (the person
      infected with the malaria parasite). Iron deficiency affects over 500 million people
      including many pregnant women and children from areas of the world that are plagued by
      malaria. Some population based studies have suggested that iron deficiency protects people
      from getting malaria and this has raised questions about the wisdom of public health policies
      that provide universal iron supplementation in countries where malaria is common. We will use
      red blood cells and sera from patients with iron deficiency anemia, hereditary
      hemochromatosis and normal individuals who are taking iron supplements to look at this
      question in a very systematic way. This study should provide information for or against a
      possible mechanism by which iron deficiency may affect the malaria parasite. The results will
      contribute to efforts to develop evidence-based public health policies on iron
      supplementation policies in malaria-endemic areas.

      There are three different types of individuals involved in this study (1) people with iron
      deficiency anemia who will be taking iron supplementation (2) people without iron deficiency
      anemia who will be taking iron supplementation and (3) people with a condition called
      hereditary hemochromatosis who have an excess of iron in their bodies.
    

Detailed description: 
      Purpose: This proposal is aimed at studying the effect of an individual's iron status and
      iron supplementation on the growth and viability of the malarial parasite Plasmodium
      falciparum. The overall goal is to provide evidence to support the development of
      evidence-based programs to improve global health policy on iron supplementation in areas of
      the world with high malaria transmission. Current WHO recommendations include routine
      supplementation of women and children. Recently however, the wisdom of this policy when
      applied to areas afflicted with high rates of malaria has come under scrutiny. This proposal
      will study the effects of red blood cells (RBCs) and sera from iron overloaded patients (with
      hereditary hemochromatosis), iron deficient patients, and iron replete individuals taking
      oral iron supplements. This proposal will attempt to identify the mechanism by which the
      human host's iron status and iron supplement use affects the growth and viability of the P.
      falciparum parasite in red blood cells.

      Participants: Healthy adult volunteers, adults with iron deficiency anemia, and patients with
      hereditary hemochromatosis will be enrolled in this study. Fifteen individuals will be
      recruited under each of the above three settings. This study involves only subjects over 18
      years of age and both males and females will be included.

      Procedures (methods): Participation in the study involves undergoing a series of screening
      tests and donation of blood and either a single time point (for hemochromatosis patients) or
      a total of three pre-specified time points (for healthy volunteers and those with iron
      deficiency). The healthy individuals will be asked to take oral iron supplements once daily
      (325 mg ferrous sulfate) for the duration of this study. Patient's blood will be separated by
      centrifugation into RBCs and sera, both of which will be used for in vitro studies on the
      impact of iron status on the growth and viability of Plasmodium falciparum.
    

Intervention name(s): Iron Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Iron supplementation (325 mg of ferrous sulfate) once daily for the 2 month duration of the study.
Other intervention name(s): Ferrous sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: anemia; malaria