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CompletedNCT05673070

Use of Ritual Prenatal Multivitamins for Pregnancy

Use of Ritual Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During Pregnancy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
City University of New York · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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=35) or another commercially available prenatal MVI (n=35) 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTRitual Epre Multivitamin-mineral supplementThe 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 MVIThe 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.

Timeline

Start date
2023-10-15
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2023-01-06
Last updated
2025-07-30

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05673070. Inclusion in this directory is not an endorsement.

Use of Ritual Prenatal Multivitamins for Pregnancy (NCT05673070) · Clinical Trials Directory