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Effect of iron supplementation on psychomotor development of non-anaemic, exclusively or predominantly breastfed infants: a randomised, controlled trial.
Chmielewska, A, Chmielewski, G, Domellöf, M, Lewandowski, Z, Szajewska, H
BMJ open. 2015;(11):e009441
Abstract
INTRODUCTION Uncertainty exists regarding the effects of iron supplementation during infancy on neurodevelopmental outcomes in the absence of anaemia. The aim of the study is to establish whether psychomotor and mental development is influenced by early iron supplementation in healthy, non-anaemic, exclusively or predominantly breastfed infants. METHODS AND ANALYSIS Healthy term infants will be recruited. If exclusively or predominantly breast fed (>50% of daily feedings) and not anaemic at 4 months, they will be randomised to receive either iron pyrophosphate (approximately 1 mg/kg) or placebo daily until 9 months of age. The primary outcome measure is neurodevelopment assessed with the Bayley Scales of Infant and Toddler Development (Bayley-III) at 12 months, and repeated at 24 and 36 months of age. Haematological parameters of iron metabolism also will be measured. ETHICS AND DISSEMINATION The Bioethics Committee of the Medical University of Warsaw approved the study protocol before recruitment started. Study results will be submitted to peer-reviewed journals in the fields of paediatrics and nutrition, and presented at relevant conferences. TRIAL REGISTRATION NUMBER NCT02242188.
2.
The role of meta-analysis in the evaluation of the effects of early nutrition on mental and motor development in children.
Szajewska, H
The American journal of clinical nutrition. 2011;(6 Suppl):1889S-1895S
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Abstract
The role of early nutrition as a cost-effective measure to ensure optimal infant growth, development, and long-term health is gaining attention. In particular, the role of supplementation with nutrients such as n-3 (omega-3) fatty acids, iron, zinc, and B vitamins, which are relevant to brain structure and function, is of interest. However, for all of these nutrients, there is a lack of clarity and no consensus regarding their role in the mental and motor development of children. Systematic reviews with or without a meta-analysis are a well-established means of reviewing existing evidence and of integrating findings from various studies, including those related to infant nutrition. In this article, I provide an overview of the basic principles of systematic review and meta-analysis of randomized controlled trials (RCTs) and summarize such evidence related to the effects of early nutrition on mental and motor development. The inclusion of only RCTs in a systematic review could be considered the major strength. Randomization is the only means to control for unknown and unmeasured differences between comparison groups as well as for those that are known and measured. However, even if only RCTs are included, reviews are not free of potential biases. An understanding of the strengths and limitations of the meta-analytic approach, which I discuss in this article, is needed by everyone involved in decision making regarding interventions assessed by this approach.