Perspectives on the design and methodology of periconceptional nutrient supplementation trials

B.J. Brabin, S. Gies, S. Owens, Y. Claeys, Umberto D'Alessandro, H. Tinto, L. Brabin

    Research output: Contribution to journalA1: Web of Science-article

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    Abstract

    Periconceptional supplementation could extend the period over which maternal and fetal nutrition is improved, but there are many challenges facing early-life intervention studies. Periconceptional trials differ from pregnancy supplementation trials, not only because of the very early or pre-gestational timing of nutrient exposure but also because they generate subsidiary information on participants who remain non-pregnant. The methodological challenges are more complex although, if well designed, they provide opportunities to evaluate concurrent hypotheses related to the health of non-pregnant women, especially nulliparous adolescents. This review examines the framework of published and ongoing randomised trial designs. Four cohorts typically arise from the periconceptional trial design - two of which are non-pregnant and two are pregnant - and this structure provides assessment options related to pre-pregnant, maternal, pregnancy and fetal outcomes. Conceptually the initial decision for single or micronutrient intervention is central - as is the choice of dosage and content - in order to establish a comparative framework across trials, improve standardisation, and facilitate interpretation of mechanistic hypotheses. Other trial features considered in the review include: measurement options for baseline and outcome assessments; adherence to long-term supplementation; sample size considerations in relation to duration of nutrient supplementation; cohort size for non-pregnant and pregnant cohorts as the latter is influenced by parity selection; integrating qualitative studies and data management issues. Emphasis is given to low resource settings where high infection rates and the possibility of nutrient-infection interactions may require appropriate safety monitoring. The focus is on pragmatic issues that may help investigators planning a periconceptional trial.
    Original languageEnglish
    JournalTrials
    Volume17
    Pages (from-to)58
    Number of pages24
    ISSN1745-6215
    DOIs
    Publication statusPublished - 2016

    Keywords

    • Prenatal health care
    • Pregnancy
    • Maternal
    • Fetal
    • Nutrition programs
    • Placenta
    • Supplementation
    • Nutrients
    • Iron
    • Folic acid
    • Compliance
    • Design
    • Methodology
    • Interventions
    • Review of the literature

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