Use of Ritual Prenatal Multivitamins for Pregnancy

Last updated: February 5, 2024
Sponsor: City University of New York
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

control MVI

Ritual Epre Multivitamin-mineral supplement

Clinical Study ID

NCT05673070
2022-0670-Brooklyn
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Pregnant women are qualified to participate if they are over 18 years of age, havingsingleton pregnancy, and without any of the conditions listed in the exclusion criteria.

Exclusion

Exclusion Criteria:

  • Exclusion criteria include diabetes, cardiovascular conditions and liver disease priorto and during pregnancy because these diseases affect metabolism of several nutrientsand thus may lead to differences in the MVI intake and nutrient status relationship.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: control MVI
Phase:
Study Start date:
October 15, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Brooklyn College of City University of New York

    Brooklyn, New York 11210
    United States

    Active - Recruiting

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Active - Recruiting

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