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Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

NCT ID: NCT05736562

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lactation Disorder - Postpartum Condition or Complication Nutrition, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women who exclusively breastfeed will be randomized at week 5 postpartum to either receive the Ritual MVI or a blank placebo for 10 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by Ritual and marked with randomly generated ID numbers. Grouping will be revealed by Ritual at end of the trial.

Study Groups

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Ritual Epre

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

Group Type EXPERIMENTAL

Ritual Epre Multimineral-Vitamin Supplement

Intervention Type DIETARY_SUPPLEMENT

The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.

Control

This group will receive a blank placebo.

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type DIETARY_SUPPLEMENT

This is a customarily designed blank placebo provided by Ritual.

Interventions

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Ritual Epre Multimineral-Vitamin Supplement

The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.

Intervention Type DIETARY_SUPPLEMENT

Placebo Control

This is a customarily designed blank placebo provided by Ritual.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Women are qualified to participate if they are over 10 years of age, having singleton pregnancy, and are exclusively breast feeding and intending to exclusively breast feed for at least 10 more weeks.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maimonides Medical Center

OTHER

Sponsor Role collaborator

City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Xinyin Jiang

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brooklyn College of City University of New York

Brooklyn, New York, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2022-0670-Brooklyn-2

Identifier Type: -

Identifier Source: org_study_id