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Perspectives on the design and methodology of periconceptional nutrient supplementation trials

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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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):
Depositing User: Julie Franco
Date Deposited: 04 Feb 2016 15:34
Last Modified: 14 Dec 2021 10:34


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