An interventional study of Vitamin B12 fortified UHT milk and Plain UHT milk in Early Pregnancy, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Not applicable, Interventional, and Health services research
Impaired vitamin B12 (B12) status during pregnancy is associated with increased risk of birth defects and common complications (e.g. intrauterine growth restriction, neural tube defects), and possibly immune function impairment. The newborns and infants of B12-deficient mothers have low B12 stores at birth, further exacerbated by a very low concentration of B12 in breast milk that may hinder their growth and development. In regions such as Bangladesh, many women of reproductive age have inadequate B12 status, probably due to low intake of animal source food. Vitamin B12 intake and status in pregnancy and lactation is potentially insufficient to prevent impaired child development and immune function related to inadequate B12 status. The investigators hypothesize that prolonged vitamin B12 supplementation through fortified milk starting from early pregnancy up to 6 mo-postpartum will improve: (1) biomarkers of vitamin B12 status in mothers-infant pairs (2) vaccine specific adaptive immunity in infants; (3) neurological and cognitive function in infants.
The investigators aim to conduct a double-blind, randomized trial, to investigate the effects of B12-fortified milk on maternal and infant B12 status, immune function and child development. Pregnant women (n=148) will be randomized to receive B12-fortified milk (100 μg/day) or milk without fortification. The daily supplementation beginning at the baseline visit (GW 11-14) will continue until 6 mo-postpartum. Biomarkers of B12 status will be measured in mothers (GW 11-14 and 6-mo postpartum) and infants (3 and 6-mo). Infant development (6 and 12-mo) will be evaluated by Bayley Scales of Infant and Toddler Development. Immune responses will be measured in infant at 3 and 6-mo. Data on socioeconomic status, dietary diversity, and anthropometric indices will be recorded at baseline. Additional tests in mothers include screening for H. pylori and plasma gastrin.
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Exclusion Criteria:
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Supplementation group (N=74) that will receive vitamin B12 fortified UHT milk daily
Dietary Supplement: Vitamin B12 fortified UHT milk
Placebo group (N=74) that will receive plain UHT milk daily
Dietary Supplement: Plain UHT milk
Daily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12
Daily intake of 200 mL of plain UHT milk
Change in concentrations of biomarkers of vitamin B12 in mother-child pairs
The investigators will determine the change in concentrations of biomarkers of B12 ( based on measurement of B12, MMA, tHcy, holoTC, cB12, folate in plasma; B12 in breast milk)
Time frame: Baseline and 6 months postpartum
Vaccine specific immunity in infants
The investigators will determine the concentrations of vaccine specific IgA and IgG in plasma
Time frame: 6 months
Cognitive, Language and Motor Composite Score
The outcomes are measured by Bayley-III test
Time frame: 12 months
Nuroinflammatory cytokines
The investigators will determine the change in concentrations of EGF and TNF-α in plasma
Time frame: 12 months
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh