Project Details

A randomized trial of lactoferrin as a gut-friendly pediatric iron source in low-resource settings

Kirkby Tickell, MBBS, MPH, PhD

Summary

BACKGROUND: Iron deficiency causes moderate and severe anemia, immunological impairment, and neurodevelopmental deficits, and is associated with linear growth failure. GAP: Lactoferrin may improve iron-associated pediatric outcomes by combatting both dietary iron deficiency and systemic inflammation. HYPOTHESIS: Lactoferrin will improve iron-associated outcomes through both lowering systemic inflammation and an increasing in total body iron. METHODS: A double-blind, placebo-controlled, randomized trial embedded in a four-arm factorial trial of lactoferrin and lysozyme for the treatment of diarrhea and malnutrition. Participants are children aged 6-24 months recovering from diarrhea and moderate or severe wasting. RESULTS: In adjusted modified Poisson models, the prevalence of anemia did not differ significantly from placebo in the intervention arms: lactoferrin RR 1.21 (95% CI 0.96 to 1.51); lysozyme RR (1.16, 95% CI 0.92 to 1.46); combination RR 1.10 (95% CI 0.87 to 1.39). Compared with placebo, none of the intervention arms showed statistically significant adjusted differences in TNF-alpha, IL-6, hepcidin, raw ferritin, inflammation-adjusted ferritin, or soluble transferrin receptor. In the combination arm, IL-6 and raw ferritin were lower than in the placebo arm, although neither difference was statistically significant: IL-6 mean difference -2.57 pg/mL (95% CI -9.06 to 3.93; p=0.437) and raw ferritin mean difference -10.70 ng/mL (95% CI -28.53 to 7.14; p=0.239). No differences neurodevelopment were observed across arms. IMPACT: Bovine source lactoferrin did not appear to modify child iron status. The combination of lactoferrin and lysozyme treatment may have influenced systemic inflammation but this result did not achieve statistical significance.