Pregnancy RelatedNCT05673070
Use of Ritual Prenatal Multivitamins for Pregnancy
A study testing Ritual Epre Multivitamin-mineral supplement in people with Pregnancy Related and Nutrition, Healthy, run by City University of New York at 2 sites in United States.
Trial 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… 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
- Pregnancy Related, Nutrition, Healthy
- What is being tested?
- Ritual Epre Multivitamin-mineral supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2023to 31 Dec 2024
- 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
- 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.
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 Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During Pregnancy
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.
- Conditions
- Pregnancy Related, Nutrition, Healthy
- Being tested
- Ritual Epre Multivitamin-mineral supplement, control MVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritual Epre Multivitamin-mineral supplementDietary 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.
control MVIDietary supplement
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.
| 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 Multivitamin-mineral supplement |
| Control MVI | Active comparator | 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. Receives: Dietary Supplement: control MVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 24 weeks of intervention
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.
Measured: after 24 weeks of intervention
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.
Measured: after 24 weeks of intervention
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.
Measured: after 24 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 posted6 Jan 2023
- Study start15 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Prenatal arm: pregnant women at gestational week 12-14 will be randomized to either receive a Ritual prenatal MVI (n=40) or a control commercially available prenatal MVI (n=40) through out pregnancy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT05673070
- Sponsor's protocol ID
- 2022-0670-Brooklyn
- Status last verified
- May 2026
- First submitted
- 6 Dec 2022
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanson I, Draicchio F, Sharafi M, Grier-Welch A, Vance A, Alamdari N, Futterman ID, Chudnoff S, Malysheva O, Caudill MA, Jiang X. A Higher-Biotin Prenatal Multivitamin Formulation Improves Maternal and Cord Blood Biotin Biomarkers: A 24-Week Double-Blind, Randomized, Controlled Trial. J Diet Suppl. 2026 Sep 4:1-17. doi: 10.1080/19390211.2026.2727024. Online ahead of print.
PubMed 42693884Draicchio 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
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 Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During Pregnancy
- ClinicalTrials.gov ID
- NCT05673070
- Acronym / sponsor ID
- 2022-0670-Brooklyn
- Conditions
- Pregnancy Related, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- City University of New YorkUniversity, hospital or other
- Collaborators
- Maimonides Medical Center
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Jan 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prenatal arm: pregnant women at gestational week 12-14 will be randomized to either receive a Ritual prenatal MVI (n=40) or a control commercially available prenatal MVI (n=40) through out pregnancy
| Arm | Type | Receives |
|---|---|---|
| Ritual Epre | Experimental | Dietary Supplement: Ritual Epre Multivitamin-mineral supplementThis group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily. |
| Control MVI | Active comparator | Dietary Supplement: control MVIFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
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 Multivitamin-mineral supplementThe Ritual Epre supplement uses methyl folate instead of folic acid and has higher vitamin D and biotin contents compared to the control supplement. | Dietary supplement | Ritual Epre |
| control MVIThe 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. | Dietary supplement | Control MVI |
Primary outcome
Folate status
Time frame: after 24 weeks of intervention
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.
Biotin status
Time frame: after 24 weeks of intervention
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.
vitamin D status
Time frame: after 24 weeks of intervention
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.
placental functional gene expression regulation
Time frame: after 24 weeks of intervention
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.
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.
- Derived from this study: PubMed 42693884Hanson I, Draicchio F, Sharafi M, Grier-Welch A, Vance A, Alamdari N, Futterman ID, Chudnoff S, Malysheva O, Caudill MA, Jiang X. A Higher-Biotin Prenatal Multivitamin Formulation Improves Maternal and Cord Blood Biotin Biomarkers: A 24-Week Double-Blind, Randomized, Controlled Trial. J Diet Suppl. 2026 Sep 4:1-17. doi: 10.1080/19390211.2026.2727024. Online ahead of print.
- Derived from this study: PubMed 41971363Draicchio 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Related
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Not yet recruitingObservational study
A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab
Pregnancy Related, Pregnancy
Not yet recruiting
Justice Core Trial
Pregnancy, Substance Use Disorder (SUD)
Active, not recruiting
Assessing the Use of Wearable Activity Trackers in a Pregnancy Cohort
Pregnancy Related
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 Multivitamin-mineral supplement in people with Pregnancy Related 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. 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?
Folate status (time frame: after 24 weeks of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673070, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 7 Nov 2026.