Use of Ritual Prenatal Multivitamins for Pregnancy

NCT05673070 | Completed

• 1 other identifier: 2022-0670-Brooklyn
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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=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

Pregnancy Related; Nutrition, Healthy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  after 24 weeks of intervention

Study Arms (2)

Ritual Epre

EXPERIMENTAL

This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.

Dietary Supplement: Ritual Epre Multivitamin-mineral supplement

Control MVI

ACTIVE COMPARATOR

For the prenatal arm, this group will receive a control multivitamin-mineral supplement pill and a 200 mg docosahexaenoic acid (DHA) pill that are commercially available.

Dietary Supplement: control MVI

Interventions

Ritual Epre Multivitamin-mineral supplement DIETARY_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.

Ritual Epre

control MVI DIETARY_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.

Control MVI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• City University of New York: lead
• Maimonides Medical Center: collaborator

Study Sites (2)

Brooklyn College of City University of New York

Brooklyn, New York, 11210, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Prenatal arm: pregnant women at gestational week 12-14 will be randomized to either receive a Ritual prenatal MVI (n=35) or a control commercially available prenatal MVI (n=35) through out pregnancy

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 6, 2023
• Study Start: October 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)