Prenatal Multivitamins for Pregnancy

No longer recruiting at 1 trial location

Overseen By Xinyin Jiang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City University of New York

Disqualifiers: Diabetes, Cardiovascular, Liver disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific prenatal multivitamin (MVI) improves nutrition for pregnant women and their babies compared to another common prenatal MVI. Researchers will compare two different multivitamins, focusing on their effects on blood nutrient levels. Women between 12-14 weeks pregnant without diabetes, heart, or liver conditions are suitable candidates. Participants will help researchers assess whether these vitamins can better support pregnancy health. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance prenatal care for future mothers and babies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Ritual Epre prenatal multivitamin is likely safe for pregnant women. Independent labs have tested this supplement to ensure it meets safety standards for heavy metals and allergens, which are important concerns during pregnancy.

The main difference between Ritual Epre and other prenatal vitamins lies in the type of folate used. Ritual Epre uses methyl folate, a form of vitamin B9 that some people find easier to absorb, while others use folic acid.

Additionally, Ritual Epre contains more vitamin D and biotin compared to the control supplement. Both are safe when taken in recommended amounts. Overall, available research indicates these vitamins are well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard prenatal multivitamins, the Ritual Epre supplement offers a novel approach by combining essential vitamins and minerals in a unique formulation. Researchers are excited about its potential to improve nutrient absorption and availability, thanks to its innovative delivery system. Additionally, the Ritual Epre supplement stands out by potentially offering enhanced support for fetal development with its carefully balanced nutrient profile. This could lead to better outcomes for both mothers and their babies compared to traditional options.

What evidence suggests that this trial's treatments could be effective for pregnancy?

Research shows that prenatal multivitamins, such as the Ritual Epre supplement, can enhance nutrition during pregnancy. In this trial, participants will receive either the Ritual Epre multivitamin-mineral supplement or a control multivitamin-mineral supplement. One study found that the Ritual multivitamin provided more effective folate, crucial for the baby's development, and 2.4 times more biotin compared to a leading prenatal vitamin. Additionally, mothers taking the Ritual multivitamin had lower cortisol levels, suggesting they might have felt less stressed. These nutrients are vital for both mother and baby, supporting healthy growth and development. While further research is beneficial, these findings suggest that Ritual Epre could be a good choice for expecting mothers. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single baby, who are not dealing with diabetes, heart conditions, or liver disease before or during pregnancy. It's designed to help those interested in optimizing their nutrition and the health of their unborn child.

Inclusion Criteria

Pregnant women with singleton pregnancy

Pregnant women without any conditions listed in the exclusion criteria

I am pregnant and over 18 years old.

Exclusion Criteria

I have had diabetes before and during my pregnancy.

I have had heart conditions before and during my pregnancy.

I have had liver disease before and during my pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Ritual prenatal MVI or another commercially available prenatal MVI throughout pregnancy

24 weeks

Blood samples collected each trimester

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• control MVI
• Placebo control
• Ritual Epre Multivitamin-mineral supplement

Trial Overview The study compares two prenatal multivitamins: Ritual Epre Multivitamin-mineral supplement and a control MVI. Participants will be randomly assigned to one of these groups and take the supplements throughout their pregnancy to see which leads to better maternal-fetal nutrition.

How Is the Trial Designed?

Group I: Ritual Epre Experimental Treatment 1 Intervention

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

Group II: Control MVI Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

City University of New York

Lead Sponsor

Trials

23

Recruited

6,000+

Maimonides Medical Center

Collaborator

Trials

72

Recruited

15,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05673070

Use of Ritual Prenatal Multivitamins for Pregnancy This study compares Ritual prenatal multivitamins to a control, using a randomized, double-blind design to assess nutrition status and health outcomes during ...

2. ritual.com ritual.com/articles/our-first-of-its-kind-prenatal-clinical-study?srsltid=AfmBOopNC8kKZiy6VYANt4nr93_Ic-YpgM88ndnTeXLX0zVF4BIZbENG

Our First-of-its-Kind Prenatal Clinical Study The study found Essential Prenatal provided more efficient folate, 2.4x more biotin, and lower cortisol levels compared to a leading prenatal. ...

3. ritual.com ritual.com/products/essential-prenatal-multivitamin?srsltid=AfmBOoooVtC-AHEbN2e_mT3dmcoHlFr57VAHBob5Z2jA4D3JqWgbWw_n

Prenatal Vitamins | Essential Prenatal Prenatal Multivitamin ; Cortisol Support*. In a clinical study, moms taking Essential Prenatal had a lower overall cortisol level during pregnancy than those ...

4. amazon.com amazon.com/Ritual-Prenatal-Vitamins-Development-Calcium-Helper/dp/B09W363MVD

Ritual Essential for Women Prenatal Multivitamin: Folate & ... This prenatal multivitamin includes Folate, Choline, Omega-3 DHA, Iron, and 12 key nutrients for before and during pregnancy, with clean, absorbable forms.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4018592/

Multivitamin Versus Multivitamin-mineral Supplementation ... In conclusion, we found that birth weight and head circumference was increased in infants whose mothers received multivitamin-mineral supplements for 5 months ...

6. ritual.com ritual.com/products/essential-prenatal-multivitamin?srsltid=AfmBOopMDrG2qkmB0I21884LXXOu_HH0CgqU6pbvazZNJny09cj8jNTY

Prenatal Vitamins | Essential Prenatal We also complete third-party testing to help ensure our products are compliant with regulations and guidelines for heavy metals, microbes, and major allergens ...

7. withpower.com withpower.com/trial/phase-lactation-disorders-2023-c7ada

Prenatal Multivitamins for Pregnancy · Info for Participants The investigators hypothesize that consumption of Ritual MVI leads to better nutrition status and biomarkers in maternal-fetal dyads compared to control during ...

8. ritual.com ritual.com/articles/pregnancy-safe-meaning?srsltid=AfmBOoq51Tujd2n3GMzs2BhLNzb7Vgl7YZYDEKMwT4VWOX3TW9eTEppe

Your Pregnancy Safe Guide to Non- ... HyaCera™ is a pregnancy-safe skincare product, evaluated in a safety study to be safe for use by pregnant and nursing women. Omega-3 DHA & EPA is a pregnancy- ...