Iron Fortified Complementary Foods Containing a Mixture of Sodium Iron EDTA with Either Ferrous Fumarate or Ferric Pyrophosphate Reduce Iron Deficiency Anemia in 12- to 36-Month-Old Children in a Malaria Endemic Setting: A Secondary Analysis of a Cluster-Randomized Controlled Trial.
Iron deficiency anemia (IDA) is a major public health problem in sub-Saharan Africa. The efficacy of iron fortification against IDA is uncertain in malaria-endemic settings. The objective of this study was to evaluate the efficacy of a complementary food (CF) fortified with sodium iron EDTA (NaFeEDTA) plus either ferrous fumarate (FeFum) or ferric pyrophosphate (FePP) to combat IDA in preschool-age children in a highly malaria endemic region. This is a secondary analysis of a nine-month cluster-randomized controlled trial conducted in south-central Côte d'Ivoire. 378 children aged 12-36 months were randomly assigned to no food intervention (n = 125; control group), CF fortified with 2 mg NaFeEDTA plus 3.8 mg FeFum for six days/week (n = 126; FeFum group), and CF fortified with 2 mg NaFeEDTA and 3.8 mg FePP for six days/week (n = 127; FePP group). The outcome measures were hemoglobin (Hb), plasma ferritin (PF), iron deficiency (PF < 30 μg/L), and anemia (Hb < 11.0 g/dL). Data were analyzed with random-effect models and PF was adjusted for inflammation. The prevalence of Plasmodium falciparum infection and inflammation during the study were 44-66%, and 57-76%, respectively. There was a significant time by treatment interaction on IDA (p = 0.028) and a borderline significant time by treatment interaction on iron deficiency with or without anemia (p = 0.068). IDA prevalence sharply decreased in the FeFum (32.8% to 1.2%, p < 0.001) and FePP group (23.6% to 3.4%, p < 0.001). However, there was no significant time by treatment interaction on Hb or total anemia. These data indicate that, despite the high endemicity of malaria and elevated inflammation biomarkers (C-reactive protein or α-1-acid-glycoprotein), IDA was markedly reduced by provision of iron fortified CF to preschool-age children for 9 months, with no significant differences between a combination of NaFeEDTA with FeFum or NaFeEDTA with FePP. However, there was no overall effect on anemia, suggesting most of the anemia in this setting is not due to ID. This trial is registered at clinicaltrials.gov (NCT01634945).
['Glinz|Dominik|D|', 'Wegmüller|Rita|R|', 'Ouattara|Mamadou|M|', 'Diakité|Victorine G|VG|', 'Aaron|Grant J|GJ|', 'Hofer|Lorenz|L|', 'Zimmermann|Michael B|MB|', 'Adiossan|Lukas G|LG|', 'Utzinger|Jürg|J|', "N'Goran|Eliézer K|EK|", 'Hurrell|Richard F|RF|']
D018798:Anemia, Iron-Deficiency D002675:Child, Preschool D016000:Cluster Analysis D007560:Cote d'Ivoire D011756:Diphosphates D004492:Edetic Acid D019353:Endemic Diseases D005290:Ferric Compounds D005293:Ferritins D005296:Ferrous Compounds D005527:Food, Fortified D006454:Hemoglobins D006801:Humans D007223:Infant D007227:Infant Nutritional Physiological Phenomena D007408:Intestinal Absorption D007501:Iron D019266:Iron, Dietary D016778:Malaria, Falciparum D013025:Soybeans D003313:Zea mays
complementary food sodium iron EDTA iron deficiency anemia cluster-randomized controlled trial iron fortification Plasmodium falciparum Côte d’Ivoire infant cereal