Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial

Authors: GALLANT, JELISA - Mount Saint Vincent University, Nova Scotia; CHAN, KATHLEEN - Mount Saint Vincent University, Nova Scotia; GREEN, TIMOTHY - South Australia Health And Medical Research Institute (SAHMRI); WIERINGA, FRANK - Institute For Research And Development (IRD); LEEMAQZ, SHALEM - South Australia Health And Medical Research Institute (SAHMRI); NGIK, REM - Helen Keller International (HKI), United States; MEASELLE, JEFFREY - University Of Oregon; BALDWIN, DARE - University Of Oregon; MAM, BORATH - Ministry Of Planning-Cambodia; SOPHONNEARY, PRAK - Ministry Of Health; YELLAND, LISA - University Of Adelaide; HAMPEL, DANIELA - University Of California, Davis; Shahab-Ferdows, Setti; Allen, Lindsay - A; JONES, KERRY - University Of Cambridge; KOULMAN, ALBERT - University Of Cambridge; PARKINGTON, DAMON - University Of Cambridge; MEADOWS, SARAH - University Of Cambridge; KROEUN, HOU - Helen Keller International (HKI), United States; WHITFIELD, KYLY - Mount Saint Vincent University, Nova Scotia

Submitted to: The American Journal of Clinical Nutrition
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 2/9/2021
Publication Date: 4/7/2021
Citation: Gallant, J., Chan, K., Green, T.J., Wieringa, F.T., Leemaqz, S., Ngik, R., Measelle, J.R., Baldwin, D., Mam, B., Sophonneary, P., Yelland, L.N., Hampel, D., Shahab-Ferdows, S., Allen, L.H., Jones, K.S., Koulman, A., Parkington, D., Meadows, S.R., Kroeun, H., Whitfield, K.C. 2021. Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial. American Journal of Clinical Nutrition. 114(1):90-100. https://doi.org/10.1093/ajcn/nqab052.
DOI: https://doi.org/10.1093/ajcn/nqab052

Interpretive Summary: Micronutrient deficiencies are a significant public health problem affecting a large portion of the world’s population. Infants, young children, adolescents and women of reproductive age including pregnant women, are especially susceptible to the health consequences of insufficient micronutrient intakes. However, micronutrient deficiencies are not routinely included in population health surveys, which limits policy, program, and promotion efforts to prevent and treat micronutrient deficiencies. To address one of the barriers to micronutrient assessment, an expert group created a consensus of a desirable target product profile (TPP) to assess micronutrient status, and a blood collection device for use in population surveys. Experts in laboratory medicine, micronutrient assessment, population-based surveys, and product development reviewed proposed TPP standards and collaboratively established minimum and optimal characteristics. These experts defined the target population as infants and children from 6-59 months, adolescents and women of reproductive age 12-49 years including pregnant women. At a minimum, the assessment tool should be a multiplex ELISA (enzyme-linked immunosorbent assay) to measure more than one analyte in a serum or plasma sample prepared from venous blood obtained by a phlebotomist with a 2-week training. Given the proposed use was specific for population surveys, experts agreed the minimum tool could be semi-quantitative, with analytical specificity of 99%. The TPP also considers the variable field environments for testing (e.g. storage conditions and time to results). The consensus TPP developed can be used to guide selection of existing technologies into population-based surveys, as well as future investment in product development. Partnerships focused on research and development—including industry, public sector, nonprofit, and academic institutions—can help advance the field and fill the micronutrient data gap.

Technical Abstract: Micronutrient deficiencies are a significant public health problem affecting a large portion of the world’s population. Disproportionately affected populations—infants, young children, adolescents and women of reproductive age including pregnant women — are especially susceptible to the health consequences of insufficient micronutrient intakes. However, assessment of micronutrient deficiencies is not routinely included in population health surveys. This nutrition data gap hampers policy, program, and promotion efforts to prevent and treat micronutrient deficiencies. To address one of the barriers to micronutrient assessment, an expert group created a consensus of a target product profile (TPP) for a micronutrient assessment tool and associated blood collection device for use in population surveys. Experts in laboratory medicine, micronutrient assessment, population-based surveys, and product development reviewed proposed TPP standards and collaboratively established minimum and optimal characteristics. These experts defined the target population as infants and children from 6-59 months, adolescents and women of reproductive age 12-49 years including pregnant women. At minimum, the assessment tool should be a multiplex ELISA formatted for >1 analyte that uses a serum or plasma sample prepared from venous blood obtained by a phlebotomist with a 2-week training. Given the use case was specific for population surveys, experts agreed the minimum tool could be semi-quantitative, with analytical specificity of 99%. The TPP also considers the variable field environments for testing (e.g. storage conditions and time to results). The consensus TPP developed can be used to guide selection of existing technologies into population-based surveys, as well as future investment in product development. Partnerships focused on research and development—including industry, public sector, nonprofit, and academic institutions—can help advance the field and fill the micronutrient data gap.