Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

Use of Ritual Epre Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During the Postpartum Period

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition, Healthy; Lactation Disorder - Postpartum Condition or Complication
• Intervention / Treatment: Dietary supplement: Ritual Epre Multimineral-Vitamin Supplement; Dietary supplement: Placebo Control

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyin Jiang, PhD; Phone Number: 2738 6072295536; Email: XinyinJiang@brooklyn.cuny.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Recruiting
      • Maimonides Medical Center
      • Contact: Itamar Futterman, MD; Phone Number: 718-283-6000; Email: IFutterman@maimonidesmed.org
    • Brooklyn, New York, United States, 11210
      • Recruiting
      • Brooklyn College of City University of New York
      • Contact: Xinyin Jiang; Phone Number: 2738 718-951-5000; Email: XinyinJiang@brooklyn.cuny.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ritual Epre; This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.	Dietary supplement: Ritual Epre Multimineral-Vitamin Supplement; The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.
Placebo Comparator: Control; This group will receive a blank placebo.	Dietary supplement: Placebo Control; This is a customarily designed blank placebo provided by Ritual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: City University of New York
• Collaborators: Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Breast Diseases; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lactation Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 2022-0670-Brooklyn-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No