Efficacy of Iron Fortified Complementary Food and IPT of Malaria in Young Children in Côte d'Ivoire
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      The proposed project is aimed at testing two interventions, namely a highly bioavailable iron
      compound and a combination of SP plus amodiaquine for intermittent preventive treatment (IPT)
      of malaria, to reduce anaemia in very young children.
    

Detailed description: 
      Efficacy study - ANAEMIA project Côte d'Ivoire The proposed project is aimed at testing two
      interventions, namely a highly bioavailable iron compound and a combination of SP plus
      amodiaquine for intermittent preventive treatment (IPT) of malaria, to reduce anaemia in very
      young children. The fortified product will be provided as porridge (Nutribon produced by PKL)
      with an optimized formula (2 mg in the form of NaFeEDTA and 3.8 mg in the form of ferrous
      fumarate) of the premix. In addition, we will assess the Nutribon product currently available
      on the market and we will compare it to an optimized premix formula. The current and the
      optimized formula contain each 2 mg iron in the form of NaFeEDTA. In addition to the NaFeEDTA
      the current premix contains 3.8 mg in the form of ferric pyrophosphate, which is less
      bioavailable than the 3.8 mg ferrous fumarate in the optimized formula. The study will be
      carried out between May and December 2012 which includes the rainy season (April - October)
      with its two peaks in Côte d'Ivoire and thus the period when malaria transmission is highest.
      The study will be implemented in a Health and Demographic Surveillance System in Taabo in
      Côte d'Ivoire and comprise 625 children between 12 to 36 months. 375 eligible infants will
      receive a fortified porridge (250 with the improved formula and 125 with the current
      formula), whereas 250 infants will continue with their local diet (control group). Infants
      receiving the optimized formula and infants in the control group will be randomly assigned to
      IPT of malaria (125 in each group) or placebo (125 in each group). Thus, infants can be
      assigned to one of the following five groups: 1. group (n=125): fortified porridge (optimized
      formula) and IPT of malaria 2. group (n=125): fortified porridge (optimized formula) and
      placebo 3. group (n=125): local diet and IPT of malaria and 4. group (n=125): local diet and
      placebo. 5. group (n=125): fortified porridge (current formula) and placebo, representing the
      current situation in Côte d'Ivoire in infants consuming fortified complementary food. This
      efficacy trial will deepen our understanding in preventing anaemia and the interaction of
      bioavailable iron compounds with an antimalarial drug and related conditions in very young
      children. Further, the study should demonstrate whether the earlier study failed to show an
      impact on anaemia due to the use of an iron compound that lacked bioavailability and/or using
      an antimalarial drug in the IPT intervention arm that lacked efficacy perhaps due to
      resistance by P. falciparum, or other yet to be investigated causes.
    

Intervention name(s): SP/amodiaquine; FeFum fortified porridge; SP/Amodiaquine + FeFum fortified porridge; Ferric pyrophosphate fortified porridge; Placebo
Intervention type(s): Drug; Dietary Supplement; Drug; Dietary Supplement; Other
Intervention description(s): One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =< 10 kg) and three daily doses of Amodiaquine (1. Day: 200 mg, 2. Day: 200 mg and 3. Day: 100 mg, or half of the dose each day if body weight =< 10 kg), every three months, i.e. 3 times during 9 consecutive months.; 6 times per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferrous fumarate) for 9 months.; One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =< 10 kg) and three daily doses of Amodiaquine (1. Day: 200 mg, 2. Day: 200 mg and 3. Day: 100 mg, or half of the dose each day if body weight =< 10 kg), every three months, i.e. 3 times during 9 consecutive months.
6 times per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferrous fumarate) for 9 months.; 6 days per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferric pyrophosphate) for 9 months.; Placebo of SP/Amodiaquine every 3 months for 9 months. No dietary intervention.
Intervention MeSH terms: Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: anemia; malaria; malnutrition; iron fortification; intermittent preventive treatment; subsaharan africa; ivory coast; young children