Lactation Disorder - Postpartum Condition or ComplicationNCT05736562
Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period
A study testing Ritual Epre Multimineral-Vitamin Supplement in people with Lactation Disorder - Postpartum Condition or Complication and Nutrition, Healthy, run by City University of New York at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Disorder - Postpartum Condition or Complication, Nutrition, Healthy
- What is being tested?
- Ritual Epre Multimineral-Vitamin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2023to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brooklyn College of City University of New York
Brooklyn, New York, 11210
Maimonides Medical Center
Brooklyn, New York, 11219
About this study
Official title: Use of Ritual Epre Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes 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.
- Being tested
- Ritual Epre Multimineral-Vitamin Supplement, Placebo Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritual Epre Multimineral-Vitamin SupplementDietary supplement
The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.
Placebo ControlDietary supplement
This is a customarily designed blank placebo provided by Ritual.
| Study group | Role | What they receive |
|---|---|---|
| Ritual Epre | Experimental | This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily. Receives: Dietary Supplement: Ritual Epre Multimineral-Vitamin Supplement |
| Control | Placebo comparator | This group will receive a blank placebo. Receives: Dietary Supplement: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk folate content
Breastmilk folate content will be measured
Measured: after 10 weeks of intervention
Breastmilk biotin content
Breastmilk biotin content will be measured.
Measured: after 10 weeks of intervention
Postpartum maternal blood folate status
Blood folate levels will be measured.
Measured: after 10 weeks of intervention
Postpartum maternal blood DHA status
Blood DHA levels will be measured.
Measured: after 10 weeks of intervention
Postpartum maternal blood vitamin B12 status
Blood B12 levels will be measured.
Measured: after 10 weeks of intervention
Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status
3-HIA will be measured
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).
Measured: at week 0 and after 10 weeks of intervention
human milk oligosaccharides (HMO)
HMOs in breastmilk will be measured throughout the study.
Measured: 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.
Measured: after 10 weeks of intervention
Breastmilk MK-7 content
Breastmilk MK-7 content will be measured.
Measured: after 10 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start15 Oct 2023
- Primary completion30 Sep 2025
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactation Disorder - Postpartum Condition or ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Maimonides Medical Center
- Responsible party
- Principal investigator, Xinyin Jiang, City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736562
- Sponsor's protocol ID
- 2022-0670-Brooklyn-2
- Status last verified
- May 2026
- First submitted
- 8 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ritual Epre Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During the Postpartum Period
- ClinicalTrials.gov ID
- NCT05736562
- Acronym / sponsor ID
- 2022-0670-Brooklyn-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- City University of New YorkUniversity, hospital or other
- Collaborators
- Maimonides Medical Center
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ritual Epre | Experimental | Dietary Supplement: Ritual Epre Multimineral-Vitamin SupplementThis group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily. |
| Control | Placebo comparator | Dietary Supplement: Placebo ControlThis group will receive a blank placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritual Epre Multimineral-Vitamin SupplementThe Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women. | Dietary supplement | Ritual Epre |
| Placebo ControlThis is a customarily designed blank placebo provided by Ritual. | Dietary supplement | Control |
Primary outcome
Breastmilk folate content
Time frame: after 10 weeks of intervention
Breastmilk folate content will be measured
Breastmilk biotin content
Time frame: after 10 weeks of intervention
Breastmilk biotin content will be measured.
Postpartum maternal blood folate status
Time frame: after 10 weeks of intervention
Blood folate levels will be measured.
Postpartum maternal blood DHA status
Time frame: after 10 weeks of intervention
Blood DHA levels will be measured.
Postpartum maternal blood vitamin B12 status
Time frame: after 10 weeks of intervention
Blood B12 levels will be measured.
Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status
Time frame: after 10 weeks of intervention
3-HIA will be measured
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).
human milk oligosaccharides (HMO)
Time frame: at week 0 and after 10 weeks of intervention
HMOs in breastmilk will be measured throughout the study.
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.
Breastmilk MK-7 content
Time frame: after 10 weeks of intervention
Breastmilk MK-7 content will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritual Epre Multimineral-Vitamin Supplement in people with Lactation Disorder - Postpartum Condition or Complication and Nutrition, Healthy, run by City University of New York at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastmilk folate content (time frame: after 10 weeks of intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.