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

City University of New York4 个研究点分布在 1 个国家目标入组 71 人开始时间: 2023年10月15日最近更新: 2026年5月19日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: City University of New York
入组人数: 71
试验地点: 4
主要终点: human milk oligosaccharides (HMO)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Investigator)

盲法说明

Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by Ritual and marked with randomly generated ID numbers. Grouping will be revealed by Ritual at end of the trial.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Ritual Epre

Experimental

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

干预措施: Ritual Epre Multimineral-Vitamin Supplement (Dietary Supplement)

Control

Placebo Comparator

This group will receive a blank placebo.

干预措施: Placebo Control (Dietary Supplement)

结局指标

主要结局

human milk oligosaccharides (HMO)

时间窗: at week 0 and after 10 weeks of intervention

HMOs in breastmilk will be measured throughout the study.

Breastmilk folate content