Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement
* Dietary Supplement: Placebo Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ritual Epre<br>This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily. | Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement<br>* The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.<br>|
| Placebo Comparator: Control<br>This group will receive a blank placebo. | Dietary Supplement: Placebo Control<br>* This is a customarily designed blank placebo provided by Ritual.<br>|

What is the study measuring?
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Primary Outcome Measures

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