OBJECTIVE: To assess the efficacy of ferrous sulfate (FS) and ferrous gluconate (FG) as fortificants for a complementary baby food (Nutrisano) to improve the iron status and to reduce the prevalence of anemia in toddlers. PATIENTS AND METHODS: Toddlers 12 to 30 months old were randomly assigned to receive either of 3 versions of Nutrisano fortified with FS or FG or not fortified (CG) for 6 months. In final blood samples, the concentrations of hemoglobin, serum ferritin, and soluble transferrin receptors (sTfR) were determined. The effects of treatment on final hemoglobin, ferritin, and sTfR were assessed by multivariate analysis. RESULTS: No significant changes in hemoglobin were observed within or among treatment groups. The prevalence of high sTfR decreased 7.1 percentage points in FG, increased 13.1 percentage points in FS, and increased 0.7 percentage points in CG (P>0.05). In an interaction between treatment and total intake of Nutrisano on the concentration of ferritin, sTfR, and total iron body stores, adjusted means of serum ferritin in the medium tertiles of intake of Nutrisano for FS (P=0.05) and in the higher and medium tertiles for FG were higher (P=0.001), and adjusted means of sTfR were significantly lower (P<0.001), than the respective lower tertile of intake. CONCLUSIONS: Fortification of Nutrisano with FG has an acceptable level of beneficial effect on markers of iron status. The satisfactory efficacy and other sensory data has led to the political decision to substitute hydrogen-reduced iron, used formerly as a fortificant, with FG. Studies to assess the effectiveness of the reformulated Nutrisano are in order.
RCT Entities:
OBJECTIVE: To assess the efficacy of ferrous sulfate (FS) and ferrous gluconate (FG) as fortificants for a complementary baby food (Nutrisano) to improve the iron status and to reduce the prevalence of anemia in toddlers. PATIENTS AND METHODS: Toddlers 12 to 30 months old were randomly assigned to receive either of 3 versions of Nutrisano fortified with FS or FG or not fortified (CG) for 6 months. In final blood samples, the concentrations of hemoglobin, serum ferritin, and soluble transferrin receptors (sTfR) were determined. The effects of treatment on final hemoglobin, ferritin, and sTfR were assessed by multivariate analysis. RESULTS: No significant changes in hemoglobin were observed within or among treatment groups. The prevalence of high sTfR decreased 7.1 percentage points in FG, increased 13.1 percentage points in FS, and increased 0.7 percentage points in CG (P>0.05). In an interaction between treatment and total intake of Nutrisano on the concentration of ferritin, sTfR, and total iron body stores, adjusted means of serum ferritin in the medium tertiles of intake of Nutrisano for FS (P=0.05) and in the higher and medium tertiles for FG were higher (P=0.001), and adjusted means of sTfR were significantly lower (P<0.001), than the respective lower tertile of intake. CONCLUSIONS: Fortification of Nutrisano with FG has an acceptable level of beneficial effect on markers of iron status. The satisfactory efficacy and other sensory data has led to the political decision to substitute hydrogen-reduced iron, used formerly as a fortificant, with FG. Studies to assess the effectiveness of the reformulated Nutrisano are in order.