Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

NCT05736562 | Active Not Recruiting

• 1 other identifier: 2022-0670-Brooklyn-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nutrition, Healthy; Lactation Disorder - Postpartum Condition or Complication

Outcome Measures

Primary Outcomes (10)

• Breastmilk folate content

  Breastmilk folate content will be measured

  after 10 weeks of intervention

• Breastmilk biotin content

  Breastmilk biotin content will be measured.

  after 10 weeks of intervention

• Postpartum maternal blood folate status

  Blood folate levels will be measured.

  after 10 weeks of intervention

• Postpartum maternal blood DHA status

  Blood DHA levels will be measured.

  after 10 weeks of intervention

• Postpartum maternal blood vitamin B12 status

  Blood B12 levels will be measured.

  after 10 weeks of intervention

• Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status

  3-HIA will be measured

  after 10 weeks of intervention

• Postpartum stress levels

  The investigators will conduct the Edinburgh Postnatal Depression Scale (EPDS) assessment (maximum score 30, range 0-30, 10 or greater is considered possible depression).

  at week 0 and after 10 weeks of intervention

• human milk oligosaccharides (HMO)

  HMOs in breastmilk will be measured throughout the study.

  at week 0 and after 10 weeks of intervention

• Potspartum maternal menaquinone-7 (vitamin K2) status

  undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured.

  after 10 weeks of intervention

• Breastmilk MK-7 content

  Breastmilk MK-7 content will be measured.

  after 10 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 Multimineral-Vitamin Supplement

Control

PLACEBO COMPARATOR

This group will receive a blank placebo.

Dietary Supplement: Placebo Control

Interventions

Ritual Epre Multimineral-Vitamin Supplement DIETARY_SUPPLEMENT

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

Ritual Epre

Placebo Control DIETARY_SUPPLEMENT

This is a customarily designed blank placebo provided by Ritual.

Control

Eligibility Criteria

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

You may qualify if:

• 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.

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 Ritual and marked with randomly generated ID numbers. Grouping will be revealed by Ritual at end of the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

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

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: October 15, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)