Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

City University of New York

Status: Enrolling

Conditions: Nutrition, Healthy; Lactation Disorder - Postpartum Condition or Complication

Treatments: Dietary Supplement: Placebo Control; Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05736562

2022-0670-Brooklyn-2

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Ritual Epre

Experimental group

Description:

This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.

Treatment:

Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement

Control

Placebo Comparator group

Description:

This group will receive a blank placebo.

Treatment:

Dietary Supplement: Placebo Control