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Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

Primary Purpose

Lactation Disorder - Postpartum Condition or Complication, Nutrition, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ritual Epre Multimineral-Vitamin Supplement
Placebo Control
Sponsored by
City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lactation Disorder - Postpartum Condition or Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Brooklyn College of City University of New York
  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ritual Epre

Control

Arm Description

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

This group will receive a blank placebo.

Outcomes

Primary Outcome Measures

Breastmilk folate content
Breastmilk folate content will be measured
Breastmilk biotin content
Breastmilk biotin content will be measured.
Postpartum maternal blood folate status
Blood folate levels will be measured.
Postpartum maternal blood DHA status
Blood DHA levels will be measured.
Postpartum maternal blood vitamin B12 status
Blood B12 levels will be measured.
Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status
3-HIA will be measured
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).
human milk oligosaccharides (HMO)
HMOs in breastmilk will be measured throughout the study.
Potspartum maternal menaquinone-7 (vitamin K2) status
undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured.
Breastmilk MK-7 content
Breastmilk MK-7 content will be measured.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2023
Last Updated
August 29, 2023
Sponsor
City University of New York
Collaborators
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05736562
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
City University of New York
Collaborators
Maimonides Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactation Disorder - Postpartum Condition or Complication, Nutrition, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ritual Epre
Arm Type
Experimental
Arm Description
This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This group will receive a blank placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ritual Epre Multimineral-Vitamin Supplement
Intervention Description
The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control
Intervention Description
This is a customarily designed blank placebo provided by Ritual.
Primary Outcome Measure Information:
Title
Breastmilk folate content
Description
Breastmilk folate content will be measured
Time Frame
after 10 weeks of intervention
Title
Breastmilk biotin content
Description
Breastmilk biotin content will be measured.
Time Frame
after 10 weeks of intervention
Title
Postpartum maternal blood folate status
Description
Blood folate levels will be measured.
Time Frame
after 10 weeks of intervention
Title
Postpartum maternal blood DHA status
Description
Blood DHA levels will be measured.
Time Frame
after 10 weeks of intervention
Title
Postpartum maternal blood vitamin B12 status
Description
Blood B12 levels will be measured.
Time Frame
after 10 weeks of intervention
Title
Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status
Description
3-HIA will be measured
Time Frame
after 10 weeks of intervention
Title
Postpartum stress levels
Description
The investigators will conduct the Edinburgh Postnatal Depression Scale (EPDS) assessment (maximum score 30, range 0-30, 10 or greater is considered possible depression).
Time Frame
at week 0 and after 10 weeks of intervention
Title
human milk oligosaccharides (HMO)
Description
HMOs in breastmilk will be measured throughout the study.
Time Frame
at week 0 and after 10 weeks of intervention
Title
Potspartum maternal menaquinone-7 (vitamin K2) status
Description
undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured.
Time Frame
after 10 weeks of intervention
Title
Breastmilk MK-7 content
Description
Breastmilk MK-7 content will be measured.
Time Frame
after 10 weeks of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyin Jiang, PhD
Phone
6072295536
Ext
2738
Email
XinyinJiang@brooklyn.cuny.edu
Facility Information:
Facility Name
Brooklyn College of City University of New York
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinyin Jiang
Phone
718-951-5000
Ext
2738
Email
XinyinJiang@brooklyn.cuny.edu
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itamar Futterman, MD
Phone
718-283-6000
Email
IFutterman@maimonidesmed.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

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