We aimed to assess non-inferiority of home fortification with 3mg iron as NaFeEDTA compared with 12.5 mg iron as ferrous fumarate in Kenyan children aged 12-36 months. We explored to what extent efficacy depended on baseline iron markers (hemoglobin concentration, plasma ferritin concentration).
338 children received premedication with dihydroartemisinin-piperaquine, albendazole and praziquantel and randomly received daily home fortification for 30 days with either 3mg iron as NaFeEDTA, 12.5mg iron as ferrous fumarate, or no iron (placebo). The primary outcome was hemoglobin concentration at 30 days after start of intervention.
At baseline, the prevalence of anemia was 62.1%, and iron deficiency occurred in 51.2% of children without inflammation (plasma concentrations of C-reactive protein <5mg/L or a1-acid glycoprotein <1g/L). 315 children completed the 30-day intervention period. Hemoglobin concentrations at 30 days after intervention (mean, SD) were 106.9g/L (13.3g/L), 110.0g/L (12.5g/L) and 108.6g/L (12.0g/L) in children who received placebo, 3mg iron as NaFeEDTA and 12.5mg iron as ferrous fumarate, respectively. Compared to placebo, 3mg as NaFeEDTA and 12.5mg as ferrous fumarate produced a difference in hemoglobin concentration of 3.0g/L (95%CI: -0.2g/L to 6.2 g/L) and 1.6 g/L (-1.6g/L to 4.8g/L), respectively (per-protocol analysis). The corresponding differences in plasma ferritin concentration were 16.2% (-14.3% to 57.7%) and 12.3% (-17.1% to 52.0%), respectively. There was no evidence of effect modification by initial iron markers.
There was no evidence that daily home fortification with either 3mg iron as NaFeEDTA or 12.5mg iron as ferrous fumarate was efficacious within the 30-day intervention period.