Abstract
BackgroundThree decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy. Early stages of iron deficiency, termed non-anemic iron deficiency (NAID), provide an opportunity for early detection and treatment before progression to IDA. There is little research regarding NAID, which may be associated with delayed development in young children. The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice, with placebo plus dietary advice, in improving developmental outcomes in children with NAID and to conduct an internal pilot study.Methods/DesignFrom a screening cohort, those identified with NAID (hemoglobin ≥110 g/L and serum ferritin <14 μg/L) are invited to participate in a pragmatic, multi-site, placebo controlled, blinded, parallel group, superiority randomized trial. Participating physicians are part of a primary healthcare research network called TARGet Kids! Children between 12 and 40 months of age and identified with NAID are randomized to receive four months of oral iron treatment at 6 mg/kg/day plus dietary advice, or placebo plus dietary advice (75 per group). The primary outcome, child developmental score, is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization. Secondary outcomes include an age appropriate behavior measure (Children’s Behavior Questionnaire) and two laboratory measures (hemoglobin and serum ferritin levels). Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression (analysis of covariance method).DiscussionThis trial will provide evidence regarding the association between child development and NAID, and the effectiveness of oral iron to improve developmental outcomes in children with NAID. The sample size of the trial will be recalculated using estimates taken from an internal pilot study.Trial registrationThis trial was registered with Clinicaltrials.gov (identifier: NCT01481766) on 22 November 2011.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0635-z) contains supplementary material, which is available to authorized users.
Highlights
Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children
This trial will provide evidence regarding the association between child development and non-anemic iron deficiency (NAID), and the effectiveness of oral iron to improve developmental outcomes in children with NAID
The sample size of the trial will be recalculated using estimates taken from an internal pilot study
Summary
Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. Selective screening should be performed at any age when these risk factors for iron deficiency and IDA have been identified [13] Both the Canadian Task Force on the Periodic Health Examination (1994) and the United States Preventive Services Task Force (2006) have concluded that the evidence is insufficient to recommend for or against routine screening for IDA in asymptomatic children [15,16]. These guidelines have focused on IDA, but have not addressed screening for non-anemic iron deficiency (NAID). Experts have highlighted the lack of evidence and paucity of high quality investigations on which to base guidelines relevant to iron deficiency [17]
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