Perspectives on the design and methodology of periconceptional nutrient supplementation trials


Brabin, BJ; Gies, S; Owens, S; Claeys, Y; D'Alessandro, U; Tinto, H; Brabin, L; (2016) Perspectives on the design and methodology of periconceptional nutrient supplementation trials. Trials, 17. ISSN 1745-6215 DOI: 10.1186/s13063-015-1124-0

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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.

Item Type: Article
Keywords: Periconceptional, Pregnancy, Placenta, Iron, Folic acid, Micronutrients, Adherence, NEURAL-TUBE DEFECTS, FOLIC-ACID SUPPLEMENTATION, RANDOMIZED, CONTROLLED-TRIAL, MULTIPLE-MICRONUTRIENT SUPPLEMENTATION, FOR-GESTATIONAL-AGE, MOTHER-CHILD COHORT, LOW-BIRTH-WEIGHT, FETAL-GROWTH, 1ST TRIMESTER, IRON STATUS
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
PubMed ID: 26833080
Web of Science ID: 369139200001
URI: http://researchonline.lshtm.ac.uk/id/eprint/2534065

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