An interventional study of Ritual Epre Multimineral-Vitamin Supplement and Placebo Control in Lactation Disorder - Postpartum Condition or Complication and Nutrition, Healthy, sponsored by City University of New York. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by City University of New York · Not applicable, Interventional, and Prevention
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.
City University of New York is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.
Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement
This group will receive a blank placebo.
Dietary Supplement: Placebo Control
The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.
This is a customarily designed blank placebo provided by Ritual.
Breastmilk folate content
Breastmilk folate content will be measured
Time frame: after 10 weeks of intervention
Breastmilk biotin content
Breastmilk biotin content will be measured.
Time frame: after 10 weeks of intervention
Postpartum maternal blood folate status
Blood folate levels will be measured.
Time frame: after 10 weeks of intervention
Postpartum maternal blood DHA status
Blood DHA levels will be measured.
Time frame: after 10 weeks of intervention
Postpartum maternal blood vitamin B12 status
Blood B12 levels will be measured.
Time frame: after 10 weeks of intervention
Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status
3-HIA will be measured
Time frame: 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).
Time frame: at week 0 and after 10 weeks of intervention
human milk oligosaccharides (HMO)
HMOs in breastmilk will be measured throughout the study.
Time frame: 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.
Time frame: after 10 weeks of intervention
Breastmilk MK-7 content
Breastmilk MK-7 content will be measured.
Time frame: after 10 weeks of intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Sep 2025, 23 months.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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City University of New York