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Perspectives on the design and methodology of periconceptional nutrient supplementation trials

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Brabin, Bernard, Gies, Sabine, Owens, Stephen, Claeys, Yves, D’Alessandro, Umberto, Tinto, Halidou and Brabin, Loretta (2016) 'Perspectives on the design and methodology of periconceptional nutrient supplementation trials'. Trials, Vol 17, Issue 58.

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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
Subjects: QU Biochemistry > Vitamins > QU 145.5 Nutritive values of food
WA Public Health > Health Problems of Special Population Groups > WA 310 Maternal welfare
WQ Obstetrics > Childbirth. Prenatal Care > WQ 175 Prenatal care
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1186/s13063-015-1124-0
Depositing User: Julie Franco
Date Deposited: 04 Feb 2016 15:34
Last Modified: 06 Feb 2018 13:11
URI: https://archive.lstmed.ac.uk/id/eprint/5612

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