Nutrition, Healthy, Pregnancy Related
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTRitual Epre Multivitamin-mineral supplement
The Ritual Epre supplement uses methyl folate instead of folic acid and has higher vitamin D and biotin contents compared to the control supplement.
DIETARY_SUPPLEMENTcontrol MVI
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.
Sponsors
City University of New York
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by the pharmacy and marked with randomly generated ID numbers. Grouping will be revealed by pharmacy at end of the trial.
Intervention model description
Prenatal arm: pregnant women at gestational week 12-14 will be randomized to either receive a Ritual prenatal MVI (n=40) or a control commercially available prenatal MVI (n=40) through out pregnancy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Pregnant women are qualified to participate if they are over 18 years of age, having singleton pregnancy, and without any of the conditions listed in the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Folate status | after 24 weeks of intervention | 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. |
| Biotin status | after 24 weeks of intervention | 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. |
| vitamin D status | after 24 weeks of intervention | 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. |
| placental functional gene expression regulation | after 24 weeks of intervention | 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. |
Countries
United States
Outcome results
None listed