Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

Not Applicable

Recruiting

• Conditions: Lactation Disorder - Postpartum Condition or Complication; Nutrition, Healthy
• Interventions: Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement; Dietary Supplement: Placebo Control

• Registration Number: NCT05736562
• Lead Sponsor: City University of New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-21
• Study Start: 2023-10-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-08-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ritual Epre	Ritual Epre Multimineral-Vitamin Supplement	This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.
Control	Placebo Control	This group will receive a blank placebo.

Primary Outcome Measures

Name	Time	Method
Breastmilk MK-7 content	after 10 weeks of intervention	Breastmilk MK-7 content will be measured.
Breastmilk folate content	after 10 weeks of intervention	Breastmilk folate content will be measured
human milk oligosaccharides (HMO)	at week 0 and after 10 weeks of intervention	HMOs in breastmilk will be measured throughout the study.
Breastmilk biotin content	after 10 weeks of intervention	Breastmilk biotin content will be measured.
Postpartum maternal blood vitamin B12 status	after 10 weeks of intervention	Blood B12 levels will be measured.
Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status	after 10 weeks of intervention	3-HIA will be measured
Postpartum maternal blood folate status	after 10 weeks of intervention	Blood folate levels will be measured.
Postpartum stress levels	at week 0 and after 10 weeks of intervention	The investigators will conduct the Edinburgh Postnatal Depression Scale (EPDS) assessment (maximum score 30, range 0-30, 10 or greater is considered possible depression).
Potspartum maternal menaquinone-7 (vitamin K2) status	after 10 weeks of intervention	undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured.
Postpartum maternal blood DHA status	after 10 weeks of intervention	Blood DHA levels will be measured.

Trial Locations

Locations (2)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

Brooklyn College of City University of New York; 🇺🇸 Brooklyn, New York, United States