Objective: To systematically review the efficacy and safety of oral Fe therapy in pre-school children (1–5 years) with non-anaemic Fe deficiency, determined by children’s developmental and haematological status and the incidence of reported side-effects.
Design: A random-effects model was used to show mean differences with 95% confidence intervals of developmental and haematological scores between Fe-treated and non-treated groups.
Setting: MEDLINE, EMBASE, Cochrane library and bibliographies of identified articles were searched up to September 2011. Randomized and observational studies were assessed by two reviewers independently. Quality of the trials was assessed on the basis of concealment of allocation, method of randomization, masking of outcome assessment and completeness of follow-up.
Subjects: From the titles of 743 articles, full text review was completed on forty-six and two randomized trials of acceptable quality met the inclusion criteria. The two trials included a total of sixty-nine children.
Results: One study showed a statistically significant difference in the post-treatment Mental Developmental Index score among children who received oral Fe therapy v. no therapy (mean difference56?3, 95% CI 1?5, 11?0, P value not provided). Both studies showed significant improvement in serum ferritin level (mg/l: mean difference551? 1, 95% CI 33?6, 68?6, P,0?01 and mean difference517?1, 95% CI 7?5, 26?6, P value not provided, respectively) in children who received Fe therapy.
Conclusions: Evidence is insufficient to recommend oral Fe therapy to children with non-anaemic Fe deficiency. There is urgent need of conducting adequately powered, randomized trials examining the efficacy of oral Fe therapy in pre-school children with non-anaemic Fe deficiency.