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

City University of New York2 sites in 1 country70 target enrollmentOctober 15, 2023

ConditionsLactation Disorder - Postpartum Condition or Complication Nutrition, Healthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lactation Disorder - Postpartum Condition or Complication
Sponsor: City University of New York
Enrollment: 70
Locations: 2
Primary Endpoint: human milk oligosaccharides (HMO)
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2023

End Date

June 30, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

City University of New York

Responsible Party

Principal Investigator

Xinyin Jiang

Associate professor

City University of New York

Eligibility Criteria

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.

Outcomes

Primary Outcomes

human milk oligosaccharides (HMO)

Time Frame: at week 0 and after 10 weeks of intervention

HMOs in breastmilk will be measured throughout the study.

Breastmilk folate content