Lucky Iron Fish Home Fortification of Iron
Condition: Anemia; Anemia, Iron-Deficiency; Hemoglobinopathies
MeSH terms: Anemia; Anemia, Iron-Deficiency; Hemoglobinopathies; Iron Deficiencies
Study type: Interventional

Summary: 
      The purpose of this research is to determine if cooking with an iron ingot called the Lucky
      Iron Fish (LIF) increases the hemoglobin status in women of childbearing age living in Preah
      Vihear, Cambodia. The investigators hypothesize that the use of the LIF during cooking over a
      12-month period will be as efficacious at increasing hemoglobin concentration as iron
      supplements (18 mg elemental iron) and will be more efficacious than the control.
    

Detailed description: 
      Background: Anemia is prevalent in Cambodia, affecting ~44% of women. The causes of anemia
      are multifactorial. Globally, the most common form is iron deficiency anemia (IDA), which can
      lead to adverse perinatal health outcomes. In Cambodia, there is evidence that suggests
      hemoglobinopathies (genetic hemoglobin [Hb] disorders) are prevalent (~50%) and are a major
      contributor to anemia. In Preah Vihear province, Cambodia, the estimated prevalence of
      malaria is ~12.3%. Malaria contributes to anemia through a decrease in the production of red
      blood cells, and an increased destruction of red blood cells.

      In Cambodia, iron supplements are recommended to treat anemia, however there is evidence of
      low compliance among women. The use of cast iron pots has proven to be an effective
      alternative to prevent and reduce IDA in developing countries. However, cast iron pots are
      not commonly used in Cambodia because they are expensive, difficult to clean, and heavy. A
      novel alternative is the Lucky Iron Fish (LIF), which is an iron ingot used during cooking as
      an in-home fortification system of iron transfer. The LIF ingot is small, lightweight, and
      easy to clean. Previous research in Cambodia confirmed the acceptance of the LIF to be high,
      but findings from this study were inconclusive and had several limitations.

      Objective: The primary objective of this study is to determine the efficacy of the LIF to
      increase Hb concentration in Cambodian women of reproductive age.

      Methods: A total of 330 women (18-49 y) with mild or moderate anemia (Hb 80-120 g/L) from
      rural Preah Vihear, Cambodia will be recruited to one of three arms to receive LIF, 18 mg
      elemental iron, or a placebo. Women with severe anemia will be excluded and referred for
      treatment. All three groups will receive nutrition education. Monitoring will be conducted
      monthly to measure compliance.

      A trained, Khmer-speaking interviewer will meet with the women to explain the details of the
      study as per the consent form. Once consent is obtained the trained interviewer will measure
      hemoglobin status using a hemocue device to confirm eligibility of the study. If eligible,
      the trained interviewer will then administer the baseline questionnaire in the participant's
      home.

      The questionnaire will collect demographic data, as well as information on current dietary
      intake, drinking water treatment, knowledge of iron deficiency anemia, knowledge of malaria,
      and perceptions of supplement use.

      Participants will have a venous blood sample taken at 0, 6, and 12 months and analyzed for
      hemoglobin and multiple biomarkers of iron status (e.g. soluble transferrin receptor,
      ferritin, and retinol binding protein (RBP)). Ferritin will be corrected for inflammation
      using measures of alpha-1 acid glycoprotein (AGP, g/L) and C-reactive protein (CRP, mg/L)
      which are biomarkers of chronic and acute inflammation, respectively.

      Genotyping will be conducted to determine the prevalence of hemoglobinopathies among women.
      The prevalence of malaria in this cohort will be determined using rapid diagnostic test kits
      for P. Falciparum, and P. Vivax at baseline, midline, and endline.

      Potential Significance: The LIF has the potential to be a low cost, effective and
      simple-to-use product to prevent and reduce iron deficiency anemia in Cambodia.
    

Intervention name(s): Lucky Iron Fish - home fortification system; 18 mg elemental iron; Nutrition Education
Intervention type(s): Other; Dietary Supplement; Other
Intervention description(s): The Lucky Iron Fish (LIF) is an ingot used during cooking as an in-home fortification system of iron. The LIF works on the same principle as cast iron pots and pans by increasing dietary intake of iron but is small and lightweight. The LIF was designed in collaboration with village elders and community members to ensure it would be accepted in Cambodia. The iron ingot resembles a local fish believed to be lucky among villages in Cambodia, contributing to the acceptability of the ingot.; This dose of iron is the recommend dietary allowance (RDA) for iron for this cohort. Women will receive one-on-one instructions on how best to consume their tablet (for example, with food).; This group will receive education containing key messages around anemia, malaria, iron intake, and dietary diversity.
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Cambodia; Iron; Childbearing Age; Women; Home Fortification