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CompletedNCT05673070Updated May 19, 2026

Use of Ritual Prenatal Multivitamins for Pregnancy

An interventional study of Ritual Epre Multivitamin-mineral supplement and control MVI in Pregnancy Related 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

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Prenatal 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. In this double-blind, randomized, controlled trial, the investigators will recruit 70 pregnant women at gestational week 12-14 and randomly assign them to either receive a Ritual prenatal MVI (n=40) or another commercially available prenatal MVI (n=40) through out pregnancy. Both supplements are over the counter and commercially available. The major differences between the two MVIs are the chemical form of folate as either 5-methyl-tetrahydrofolate or folic acid, and the dosages of vitamin D, biotin, and docosahexaenoic acid. The investigators will collect blood samples in each trimester of pregnancy and the placenta and cord blood at delivery to assess differences in blood nutrient levels. The investigators hypothesize that consumption of Ritual MVI leads to better nutrition status and biomarkers in maternal-fetal dyads compared to control during the antepartum period.

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Conditions studied

  • Pregnancy Related
  • Nutrition, Healthy
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In context

Lead sponsor

City University of New York is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Pregnant women are qualified to participate if they are over 18 years of age, having singleton pregnancy, and without any of the conditions listed in the exclusion criteria.

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Ritual Epre

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

    Dietary Supplement: Ritual Epre Multivitamin-mineral supplement

  • Active comparator
    Control MVI

    For the prenatal arm, this group will receive a control multivitamin-mineral supplement pill and a 200 mg docosahexaenoic acid (DHA) pill that are commercially available.

    Dietary Supplement: control MVI

Interventions

  • Dietary supplementRitual Epre Multivitamin-mineral supplement

    The Ritual Epre supplement uses methyl folate instead of folic acid and has higher vitamin D and biotin contents compared to the control supplement.

  • Dietary supplementcontrol MVI

    The control MVI supplement is a commercially available product from another brand. Since this MVI doesn't contain DHA, a pill of DHA will also be provided to participants in this group.

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What researchers measure

Primary outcomes

  1. Folate status

    The investigators hypothesize that the group that consumes Ritual would have less unmetabolized folic acid in the blood than the control group. A greater proportion of participants would have supranutritional levels of folate (\> 20 ng/mL serum folate) in the control versus Ritual group.

    Time frame: after 24 weeks of intervention

  2. Biotin status

    The investigators hypothesize that the group that consumes Ritual would have higher levels of biotin and lower levels of 3-HIA and 3-HIA-carnitine in the maternal and cord blood than the control group.

    Time frame: after 24 weeks of intervention

  3. vitamin D status

    The investigators hypothesize that the group that consumes Ritual would have higher levels of vitamin D metabolites in the maternal and cord blood than the control group.

    Time frame: after 24 weeks of intervention

  4. placental functional gene expression regulation

    The investigators hypothesize that the group that consumes Ritual would have higher expression of vitamin D response genes and lower expression of inflammatory and stress genes.

    Time frame: after 24 weeks of intervention

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Study locations

2 sites
  • Brooklyn College of City University of New York
    Brooklyn, New York 11210, United States
  • Maimonides Medical Center
    Brooklyn, New York 11219, United States
08

References and documents

Publications

  • Draicchio F, Hausser J, Sharafi M, Grier-Welch A, Vance A, Alamdari N, Futterman ID, Chudnoff S, Malysheva O, Caudill MA, Hanson I, Jiang X. Using 6S-5-methyltetrahydrofolate instead of folic acid in prenatal multivitamin reduces unmetabolized folic acid concentrations in the mother-fetus dyad: a 24-week randomized controlled trial. Front Nutr. 2026 Mar 26;13:1679067. doi: 10.3389/fnut.2026.1679067. eCollection 2026. PubMed 41971363 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2023 to primary completion in Dec 2024, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2022
First posted
Jan 6, 2023
StartActual
Oct 15, 2023
Primary completionActual
Dec 31, 2024
CompletionActual
Dec 31, 2024
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05673070
Lead sponsor
City University of New York
Collaborators
Maimonides Medical Center
Responsible party
Xinyin Jiang (Associate professor, City University of New York) — Principal investigator
First posted
Jan 6, 2023
Start date
Oct 15, 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
May 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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