Journal ArticleOpen Access
Micronutrient Biomarker Selection and Assay Methods and Performance in Double-Blind, Randomized, Controlled Micronutrient Dose Response (MiNDR) Trials among Women of Reproductive Age and Pregnant Women in Rural Bangladesh
Author Affiliations
Johns Hopkins University, International Centre for Diarrhoeal Disease Research, University of Maryland, Baltimore
Published InCurrent Developments in Nutrition
Year2025
Abstract
Background: Comprehensive documentation of micronutrient biomarker assessments, capturing status from deficiency to excess, remains limited, specifically in the context of multiple micronutrient supplementation (MMS) trials. Objectives: We document biomarker selection, preanalytical and analytical methods, assay performance evaluation, and biomarker interpretation for modeling the dose-response effects of MMS in 2 parallel bioefficacy trials among women of reproductive age and pregnant women in rural Bangladesh. Methods: Blinded analysis of biomarker assays is being performed in the field and at 2 laboratories. Automated clinical chemistry analyzers are used to measure conventional serum and plasma biomarkers of vitamin D, B12, folate, iron, inflammation, iodine, and bone turnover. Plasma vitamers of A, E, B2, and B6, and urinary B1, B2, and B3 are measured by…
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