NCT05736562

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: City University of New York · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Lactation Disorder - Postpartum Condition or Complication
• Nutrition, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ritual Epre Multimineral-Vitamin Supplement	The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.
DIETARY_SUPPLEMENT	Placebo Control	This is a customarily designed blank placebo provided by Ritual.

Timeline

• Start date: 2023-10-15
• Primary completion: 2025-09-30
• Completion: 2026-06-30
• First posted: 2023-02-21
• Last updated: 2025-12-29

Locations

2 sites across 1 country: United States