Prenatal multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. In this double-blind, randomized, controlled trial, the investigators will recruit 70 pregnant women at gestational week 12-14 and randomly assign them to either receive a Ritual prenatal MVI (n=40) or another commercially available prenatal MVI (n=40) through out pregnancy. Both supplements are over the counter and commercially available. The major differences between the two MVIs are the chemical form of folate as either 5-methyl-tetrahydrofolate or folic acid, and the dosages of vitamin D, biotin, and docosahexaenoic acid. The investigators will collect blood samples in each trimester of pregnancy and the placenta and cord blood at delivery to assess differences in blood nutrient levels. The investigators hypothesize that consumption of Ritual MVI leads to better nutrition status and biomarkers in maternal-fetal dyads compared to control during the antepartum period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
The Ritual Epre supplement uses methyl folate instead of folic acid and has higher vitamin D and biotin contents compared to the control supplement.
The control MVI supplement is a commercially available product from another brand. Since this MVI doesn't contain DHA, a pill of DHA will also be provided to participants in this group.
Brooklyn College of City University of New York
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Folate status
The investigators hypothesize that the group that consumes Ritual would have less unmetabolized folic acid in the blood than the control group. A greater proportion of participants would have supranutritional levels of folate (\> 20 ng/mL serum folate) in the control versus Ritual group.
Time frame: after 24 weeks of intervention
Biotin status
The investigators hypothesize that the group that consumes Ritual would have higher levels of biotin and lower levels of 3-HIA and 3-HIA-carnitine in the maternal and cord blood than the control group.
Time frame: after 24 weeks of intervention
vitamin D status
The investigators hypothesize that the group that consumes Ritual would have higher levels of vitamin D metabolites in the maternal and cord blood than the control group.
Time frame: after 24 weeks of intervention
placental functional gene expression regulation
The investigators hypothesize that the group that consumes Ritual would have higher expression of vitamin D response genes and lower expression of inflammatory and stress genes.
Time frame: after 24 weeks of intervention
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