Clinical trial NCT05736562: Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period
Official title: Use of Ritual Epre Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During the Postpartum Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lactation Disorder - Postpartum Condition or Complication
Nutrition, Healthy
Lead sponsor: City University of New York
Sponsor class: OTHER
Collaborators: name: Maimonides Medical Center
First posted: 2023-02-21
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women who exclusively breastfeed will be randomized at week 5 postpartum to either receive the Ritual MVI or a blank placebo for 10 weeks.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Breastmilk folate content
timeFrame: after 10 weeks of intervention
measure: Breastmilk biotin content
timeFrame: after 10 weeks of intervention
measure: Postpartum maternal blood folate status
timeFrame: after 10 weeks of intervention
measure: Postpartum maternal blood DHA status
timeFrame: after 10 weeks of intervention
measure: Postpartum maternal blood vitamin B12 status
timeFrame: after 10 weeks of intervention
measure: Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status
timeFrame: after 10 weeks of intervention
measure: Postpartum stress levels
timeFrame: at week 0 and after 10 weeks of intervention
measure: human milk oligosaccharides (HMO)
timeFrame: at week 0 and after 10 weeks of intervention
measure: Potspartum maternal menaquinone-7 (vitamin K2) status
timeFrame: after 10 weeks of intervention
measure: Breastmilk MK-7 content
timeFrame: after 10 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn College of City University of New York
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
References: