Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

Last updated: July 28, 2025
Sponsor: City University of New York
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo Control

Ritual Epre Multimineral-Vitamin Supplement

Clinical Study ID

NCT05736562
2022-0670-Brooklyn-2
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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. It is, however, largely unknown whether using an MVI during the lactating period helps improve nutrition status of mom and baby. In this double-blind, randomized, controlled trial, the investigators will recruit 7- postpartum women who exclusively breastfeed at week 5 postpartum and randomly assign them to either receive the Ritual MVI which is commercially available or a blank placebo for 10 weeks. A blank placebo is appropriate because there is currently no recommendation or scientific consensus that lactating women who are healthy and eat a normal diet would have improved nutrition status or maternal-infant health outcomes from a nutrition supplement. The investigators will collect blood and breastmilk samples at baseline and end of the study to assess nutrient status. The investigators hypothesize that consumption of a Ritual MVI leads to better nutrition status and biomarkers in maternal-child dyads compared to control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women are qualified to participate if they are over 10 years of age, havingsingleton pregnancy, and are exclusively breast feeding and intending to exclusivelybreast feed for at least 10 more weeks.

Exclusion

Exclusion Criteria:

  • Exclusion criteria include diabetes, cardiovascular conditions and liver diseaseprior to and during pregnancy because these diseases affect metabolism of severalnutrients and thus may lead to differences in the MVI intake and nutrient statusrelationship.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Placebo Control
Phase:
Study Start date:
October 15, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Brooklyn College of City University of New York

    Brooklyn, New York 11210
    United States

    Site Not Available

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Site Not Available

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