Our First-of-its-Kind Prenatal Clinical Study

A win for women’s health: Our gold-standard prenatal clinical study is completed — making [Essential Prenatal Multivitamin] the only leading prenatal supported by its own human clinical trial.‡†

‡Based on net sales from industry data including Nielsen IQ, Stackline, and Numerator as of Q4, 2024 and top 5 products. †Based on a 24-week, randomized, double-blind, controlled clinical trial on 62 second and third trimester pregnant women.

Why We Invested In A Clinical Trial

Ever wondered what your prenatal multivitamin actually does?

You’d think that as the go-to supplement for nutrient support during pregnancy, the prenatal multivitamin category would be backed by extensive clinical research on the exact benefits for mom and baby. It just makes sense, right?

Wrong.

Frustratingly, women, and pregnant women in particular, have historically been an afterthought in clinical studies and healthcare. In fact, women were routinely excluded from clinical trials until 1993, leaving many existing healthcare and nutrition recommendations based on data extrapolated from studies conducted on men. This has made it more difficult to understand the unique needs and hormonal changes experienced by women, especially during pregnancy.1

Many leading prenatal multivitamins aren’t backed by a clinical study on their product—yet they’re intended to support mom and baby through one of the most critical phases of their lives.

Our Findings

After the completion of our 24-week study, we compiled data into five key learnings about the impact of our #1 bestselling‡ Essential Prenatal Multivitamin for mom and baby. When compared with another leading prenatal in a clinical trial over 24 weeks, Essential Prenatal was clinically proven to...

1. Support adequate folate levels. Moms taking Essential Prenatal maintained adequate folate levels throughout pregnancy. Further, Essential Prenatal provided a more efficient utilization of folate vs. a leading prenatal with folic acid. Folate in Essential Prenatal was proven to be well-absorbed. †*

Why this matters:

• Pregnant women require increased folate to support healthy fetal development. However, there are multiple forms of the same nutrient (folate) that both help support adequate folate levels.2

• Folic acid is the synthetic form of folate that must be converted to methylated folate (5-MTHF) in the body to be biologically active.

• Ritual’s Essential Prenatal Multivitamin contains methylated folate in order to bypass common gene variations that make the folic acid-to-methylated folate conversion more difficult for up to 1/3 of people.*3

• Moms taking Essential Prenatal had less unmetabolized folic acid (UMFA) in their blood and the placenta compared to a leading prenatal in our clinical study.†* Previous literature supports this finding.4

• In the current clinical study, 29% of women taking a leading prenatal exceeded the Tolerable Upper Intake Level (UL) for folate. In contrast, 100% of women taking Essential Prenatal remained within safe intake levels.†*

2. Supports increased biotin demands during pregnancy. Moms taking Ritual had 2.4x more biotin in their blood than those taking a leading prenatal.†* Biotin supports metabolic demand.

Why this matters:

• Research indicates that current recommendations for certain nutrients like biotin might be too low.5

• At least one-third of pregnant women experience marginal biotin deficiencies.5

• Biotin is crucial for metabolism, gene regulation, and cellular function.*6 Despite its importance, many prenatal multivitamins lack sufficient biotin.

3. Supports healthy cortisol levels. Moms taking Ritual had a lower overall blood cortisol level during pregnancy than those taking a leading prenatal.†*

Why this matters:

• Cortisol, the body's primary stress hormone, rises during pregnancy as part of the normal physiological changes.

• Managing cortisol levels can be important for supporting a healthy pregnancy for both mom and baby.*7

4. Help support baby’s bone health, as seen through higher umbilical cord blood P1NP levels. P1NP is procollagen type 1 N-terminal propeptide, and acts as a measure of bone formation.†*

5. Gentler on the stomach. Moms taking Ritual rated Essential Prenatal to be easier to swallow, gentler on the stomach, and had a better overall positive experience than those taking a leading prenatal.†*

All in all, we can confidently state that according to the evidence, Essential Prenatal is clinically proven to support a healthy pregnancy for mom and baby.†*

Our Study Design

Methodology matters — it’s the differences between a well-designed clinical study that is able to demonstrate proof of claims, and a bogus one.

(You should know, within the supplement industry, the existing regulation around what constitutes a “clinical study” is seriously outdated. Ritual has historically led lobbying efforts for updated regulations.)

The Ritual Essential Prenatal Clinical Study was conducted in partnership with Brooklyn College of the City University of New York (CUNY), the Department of Obstetrics and Gynecology at Maimonides Medical Center, and Cornell University. We employed a randomized, double-blind, controlled design and the study spanned a duration of 24 weeks during the second and third trimesters of pregnancy. Participants were enrolled as healthy, second trimester pregnant women aged 21 to 45. Maternal blood samples were taken at baseline, week 12, and week 24 of the study. Umbilical cord blood and placenta samples were collected upon delivery.

A total of 62 participants completed the study, with 31 participants in each group. The average age was 32 years, ranging from 21 to 45 years. Our sample included a range of educational backgrounds and marital statuses. 33.9% of participants identified as White, 29.0% as Black, 22.6% as Asian, and 14.5% reporting another race. Additionally, 66% of participants identified as non-Hispanic or Latino, while 34% identified as Hispanic or Latino.

Our Clinical Record

Despite the critical importance of maternal health during pregnancy, much of the existing research on nutrition, supplementation, and health outcomes often overlooks the specific challenges women face during this time.

Ritual’s goal is to change this standard, not just to advance research on our own products, but to advance women’s health research as a whole. Our clinical trial for Essential Prenatal Multivitamin adds to our record of clinical-tested-and-proven products, including:

Essential for Women 18+ Multivitamin

Sleep BioSeries™

Hyacera™ Skin Hydration

We’ve set the public goal of completing clinical trials on 100% of our products by 2030. We’ll also use our advocacy platform to push for more inclusive and comprehensive studies that prioritize women, especially during pregnancy.

Why? Because women deserve care that actually works for them. And that’s what we’re here for.

References:

1. Office of Research on Women’s Health. History of Women’s Participation in Clinical Research. National Institutes of Health, Department of Health & Human Services, 2024.
2. Office of Dietary Supplements. Folate: Fact sheet for Health Professionals. National Institutes of Health, Department of Health & Human Services, 2022.
3. Tsang BL, Devine OJ, Cordero AM, et al. Assessing the association between the methylenetetrahydrofolate reductase (MTHFR) 677>T polymorphism and blood folate concentrations: A systematic review and meta-analysis of trials and observational studies. Am J Clin Nutr. 2015;101(6):1286-1294.
4. Cochrane KM, Elango R, Devlin AM, Mayer C, Hutcheon JA, Karakochuk CD. Supplementation with (6S)-5-methyltetrahydrofolic acid appears as effective as folic acid in maintaining maternal folate status while reducing unmetabolised folic acid in maternal plasma: a randomised trial of pregnant women in Canada. British Journal of Nutrition. 2024;131(1):92-102. doi:10.1017/S0007114523001733
5. Perry CA, West AA, Gayle A, Lucas LK, Yan J, Jiang X, Malysheva O, Caudill MA. Pregnancy and lactation alter biomarkers of biotin metabolism in women consuming a controlled diet. J Nutr. 2014 Dec;144(12):1977-84. doi: 10.3945/jn.114.194472. Epub 2014 Aug 13. PMID: 25122647; PMCID: PMC4230210.
6. Ichihara Y, Suga K, Fukui M, Yonetani N, Shono M, Nakagawa R, Kagami S. Serum biotin level during pregnancy is associated with fetal growth and preterm delivery. J Med Invest. 2020;67(1.2):170-173. doi: 10.2152/jmi.67.170. PMID: 32378602.
7. Shriyan P, Sudhir P, van Schayck OCP, Babu GR. Association of high cortisol levels in pregnancy and altered fetal growth. Results from the MAASTHI, a prospective cohort study, Bengaluru. Lancet Reg Health Southeast Asia. 2023 Jul;14:100196. doi: 10.1016/j.lansea.2023.100196. PMID: 37461746; PMCID: PMC7614758.

‡Based on net sales from industry data including Nielsen IQ, Stackline, and Numerator as of Q4, 2024 and top 5 products.

†Based on a 24-week, randomized, double-blind, controlled clinical trial on 62 second and third trimester pregnant women.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease