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 in iron-associated 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: Pending. IMPACT: This embedded trial will provide the necessary data to design and justify large Phase III clinical trials testing the superiority of lactoferrin to available iron supplements among children with iron deficiency in LMICs. Separately, this embedded trial may lead to trials testing the inclusion of lactoferrin in therapeutic foods for children with wasting.