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OpenTrials
Completed

NCT Number: NCT05736562

Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period

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.

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Key information

Conditions

Lactation Disorder - Postpartum Condition or Complication Nutrition, Healthy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brooklyn College of City University of New York, Brooklyn, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ritual Epre Multimineral-Vitamin Supplement

Dietary Supplement

The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.

Placebo Control

Dietary Supplement

This is a customarily designed blank placebo provided by Ritual.

Primary outcomes

  1. Breastmilk folate content

    Time frame: after 10 weeks of intervention

    Breastmilk folate content will be measured

  2. Breastmilk biotin content

    Time frame: after 10 weeks of intervention

    Breastmilk biotin content will be measured.

  3. Postpartum maternal blood folate status

    Time frame: after 10 weeks of intervention

    Blood folate levels will be measured.

  4. Postpartum maternal blood DHA status

    Time frame: after 10 weeks of intervention

    Blood DHA levels will be measured.

  5. Postpartum maternal blood vitamin B12 status

    Time frame: after 10 weeks of intervention

    Blood B12 levels will be measured.

  6. Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status

    Time frame: after 10 weeks of intervention

    3-HIA will be measured

  7. Postpartum stress levels

    Time frame: at week 0 and after 10 weeks of intervention

    The investigators will conduct the Edinburgh Postnatal Depression Scale (EPDS) assessment (maximum score 30, range 0-30, 10 or greater is considered possible depression).

  8. human milk oligosaccharides (HMO)

    Time frame: at week 0 and after 10 weeks of intervention

    HMOs in breastmilk will be measured throughout the study.

  9. Potspartum maternal menaquinone-7 (vitamin K2) status

    Time frame: after 10 weeks of intervention

    undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured.

  10. Breastmilk MK-7 content

    Time frame: after 10 weeks of intervention

    Breastmilk MK-7 content will be measured.

Sponsors and collaborators

Lead sponsor

City University of New York

Other

Collaborators

  • Maimonides Medical Center

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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