Objectives: We assessed whether Helicobacter pylori eradication was followed by changes in iron stores among non-iron-deficient children.
Materials and methods: Double-blind randomized intervention trial on 110 asymptomatic 3- to 10-year-olds with H pylori infection assigned to any of the following 4 arms: both quadruple eradication and iron supplementation, either quadruple sequential eradication or iron supplementation, or placebo only. Hemoglobin, transferrin saturation, and serum ferritin were measured at baseline and 8 months later to assess changes according to study arm, H pylori infection status at ≥45 days, and cytotoxin-associated gene product A status.
Results: Intent-to-treat (n = 110) and per-protocol (n = 90) analyses revealed no differences across study arms in changes of iron stores. However, we found that those who had their infection eradicated had a 3-fold increased average change from baseline serum ferritin compared with that of children who remained infected (P < 0.05). Eradication of infection by cytotoxin-associated gene product A negative strains was associated with a larger ferritin increase.
Conclusions: In this double-blind randomized trial, the first among non-iron-deficient, asymptomatic H pylori-infected children living in the contiguous United States, we found no effect of H pylori eradication regarding changes in iron stores. However, those who had their infection eradicated at follow-up had a significantly larger increase in serum ferritin from baseline.
Trial registration: ClinicalTrials.gov NCT00364104.