Treatment of Iron Deficiency Anemia in Malaria Endemic Ghana
Condition: Anemia
MeSH terms: Malaria; Anemia; Iron Deficiencies
Study type: Interventional

Summary: 
      Iron deficiency and iron deficiency anemia (IDA) are the most prevalent micronutrient
      deficiencies on a worldwide basis, especially in developing countries. The impact of severe
      IDA can have mortal consequences, since without adequate hemoglobin, the brain and body
      become deprived of oxygen and, if allowed to continue, death may ensue. It has been shown
      that iron supplementation in infants and young children can enhance child development,
      however, it may also result in increased rates of malaria in high burden areas.

      The primary objective of this study is to determine the impact of providing encapsulated iron
      (as a powder added to complementary foods) on the susceptibility to clinical malaria among
      anemic and non-anemic infants and young children (6-24 months of age) living in a high
      malaria burden area.

      The value of performing this research in Ghana is primarily that malaria and anemia remain
      the most important causes of death and morbidity.
    

Detailed description: 
      Study Design:

      The proposed study is a community-based blinded randomized controlled trial with 2 study arms
      that will be conducted in two phases:

        -  Phase I will take place during the dry season (December to April), when malaria
           transmission rates are lower. Eligible subjects (one per household) will be individually
           randomized to receive a daily dose of either a powdered vitamin/mineral fortificant
           containing 12.5 mg of iron (plus ascorbic acid, vitamin A and zinc), or a placebo
           (containing all micronutrients excluding iron), added to complementary foods, for 5
           months.

        -  Phase II will take place during the wet season (June to October), when malaria
           transmission rates are higher. Eligible subjects, who did not participate in Phase I,
           will be individually randomized to one of the two study arms as described above and
           followed for 5 months.

      A dual phase design, with two unique cohorts, was chosen so that preliminary results (at the
      end of phase 1) could be assessed by an independent Data Safety and Monitoring Committee. It
      is possible that during the dry season no impact of iron will be detected, while during the
      wet season, an impact will be observed. With this possible outcome, it is potentially
      feasible to translate this knowledge into a Ministry of Health Program to only provide iron
      supplementation (fortification) during the dry months of the year (December to April).
    

Intervention name(s): Sprinkles®; vitamin/mineral fortificant without iron
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): powdered vitamin/mineral fortificant WITH iron sprinkled onto food once a day for 5 months; powdered vitamin/mineral fortificant WITHOUT iron sprinkled onto food once a day for 5 months
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Iron deficiency anemia; Sprinkles®; micronutrients; malaria incidence; iron supplement