Perspectives on the design and methodology of periconceptional nutrient supplementation trials
Year: 2016
Type: article
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.
Source: Trials
Institutions: University of Liverpool, Liverpool School of Tropical Medicine, University of Amsterdam, Instituut voor Tropische Geneeskunde, Northumbria Healthcare NHS Foundation Trust, London School of Hygiene & Tropical Medicine, MRC Unit the Gambia, Medical Research Council, Clinical Research Unit Nanoro, University of Manchester
Language: English
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,790
Funders: Office of Dietary Supplements, Bill and Melinda Gates Foundation, Instituut voor Tropische Geneeskunde, National Institute for Health and Care Research, Università degli Studi G. d'Annunzio Chieti - Pescara, National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development
OpenAlex ID: W2262855078