a1 Division of Pediatric Medicine and the Pediatric Outcomes Research Team (PORT), Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, Canada, M5G 1X8
a2 Departments of Pediatrics, and Health Policy, Management and Evaluation, Faculty of Medicine, University of Toronto, Toronto, Canada
a3 Department of Pediatrics, Mount Sinai Hospital, University of Toronto, Toronto, Canada
a4 Hospital Library and Archives, Hospital for Sick Children, Toronto, Canada
a5 Child Health Evaluation Program, Hospital for Sick Children Research Institute, Toronto, Canada
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 difference = 6·3, 95 % CI 1·5, 11·0, P value not provided). Both studies showed significant improvement in serum ferritin level (μg/l: mean difference = 51·1, 95 % CI 33·6, 68·6, P < 0·01 and mean difference = 17·1, 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.
(Received September 04 2011)
(Revised June 05 2012)
(Accepted June 29 2012)
(Online publication August 16 2012)